Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2951529

FEI Number

1000307109

Entity Name

VORTRAN MEDICAL TECHNOLOGY 1, INC.

City/State/Country

SACRAMENTO, CA, US

Establishment Address

21 Goldenland Court, Suite 100, SACRAMENTO, CA 95834, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VORTRAN MEDICAL TECHNOLOGY 1, INC. (Owner Number: 2082582)

Owner / Operator Contact Address

21 GOLDENLAND COURT, SUITE 100, Sacramento, CA 95834, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K072634

PMA Number

N/A

All Registered Proprietary Names

VORTRAN Airway Pressure Monitor Connection Kits VORTRAN APM-3900 Adult Model PercussiveTech HF PercussiveNEB VAR-Plus Model PCM/PCE VORTRAN APM-Plus VORTRAN GO2VENT with PEEP Valve VORTRAN Cuff Inflator (VCI) VORTRAN Manometer VORTRAN Medical Air Compressor (V-M.A.C.)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2011-12-20
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2007-12-18
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2007-12-18
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2019-12-23
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2021-04-13
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2018-07-24
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2016-10-24
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2017-11-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VORTRAN MEDICAL TECHNOLOGY 1, 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
K812140	3M Company	BIRD MEAN AIRWAY PRESSURE MONITOR	1981-08-20
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Z-0006-2014	H & H Associates	2	H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part *H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708*. The product is used to maintain fracture alignment.

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1218704	BIO-MED DEVICES, INC.	GUILFORD, CT, US
3008729547	GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.	JUAREZ Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2951529. Last updated year: 2026. Please use registration number 2951529 when referencing this establishment in official correspondence.