Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1932668

FEI Number

1000138417

Entity Name

MOLDED PRODUCTS INC.

City/State/Country

HARLAN, IA, US

Establishment Address

1812 Industrial Pkwy, HARLAN, IA 51537, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

MOLDED PRODUCTS INC. (Owner Number: 9007334)

Owner / Operator Contact Address

1112 CHATBURN AVE., --, Harlan, IA 51537, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K022068

PMA Number

N/A

All Registered Proprietary Names

FISTULA PRESSURE DRESSING CLAMP, Includes MPC-260, -260B, -250, -250XL Collection Assist Device Includes MPC-745 Safety Visor & 2 Shields Includes MPC-305 FISTULA PRESSURE CLAMP 'ULTRA GRIP' COVER, Includes MPC-255 TRANSDUCER PROTECTOR, DIALYSIS, Includes MPC-80, -85 Mid-America MINI-OPT Safety Visor w/2 Shields, Includes MPC-300, -301, -302, -303. Plus Disposable Face-Shield MPC-318 Disposable Storage Caps Includes MPC-60B, -60D, -50DV, -40, -45 "ENCASE" FISTULA NEEDLE ENCAP HOLDER, Includes MPC-375 MedErect Vacuum Therapy System INJECTION LUER CAPS/PLUGS, Includes MPC-100, -124, -115, -123, -135 Re-Use/Wash-Out Lines w/connectors Includes MPC-660, -640, -720, -710, -620, -715, -650, -705, -700 Female Urethra Catheterization - Assisting Device Includes FS-1700 Plastic Thumb Forcep includes MPC-3000 Dialyzer Holder Includes MPC-1405, -1415, -1425 FISTULA PRERSSURE DRESSING STRAP/TOURNIQUET, Includes MPC-350 LUER TO LUER ADAPTER, Includes MPC-150, -155, -160 DIALYSATE TUBING W/ HANSEN CONNECTORS Includes MPC-725, -740

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	1996-08-08
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2010-04-14
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-02-14
NOO	Clamp, Dialysis Arm	Gastroenterology, Urology	Class 1	876.5540	2005-06-27
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2020-11-25
FIB	Protector, Transducer, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2007-11-28
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	1996-10-24
FJI	Dialyzer, Capillary, Hollow Fiber	Gastroenterology, Urology	Class 2	876.5820	2007-11-29
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1999-08-06
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	Class 2	876.5020	2008-04-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-29
FID	Tubing, Dialysate	Gastroenterology, Urology	Class 2	876.5820	2007-11-29
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2022-01-10
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2013-09-20
MON	System, Hemodialysis, Remote Accessories	Gastroenterology, Urology	Class 1	876.5820	2008-06-27
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	1999-08-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-29
FID	Tubing, Dialysate	Gastroenterology, Urology	Class 2	876.5820	2007-11-28

Official Correspondent

SHERI Tyrrel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MOLDED PRODUCTS INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864831	Cobe Laboratories, Inc.	COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS	1987-03-27
K772290	Redy Laboratories	DIALYZER, CAPILATORY, HOLLOW FIBER	1978-03-15
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0041-2026	Fresenius Medical Care Holdings, Inc.	2	Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1932668. Last updated year: 2026. Please use registration number 1932668 when referencing this establishment in official correspondence.