PNEO, LLC

FDA Device Registration & Listing · Denton, TX, US · Registration 3011418975

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011418975
FEI Number
3011418975
Entity Name
PNEO, LLC
City/State/Country
Denton, TX, US
Establishment Address
204 Cardinal Drive, Denton, TX 76209, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
pNeo, LLC (Owner Number: 10048567)
Owner / Operator Contact Address
204 Cardinal Drive, Denton, TX 76209, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Shusher Care Shusher Care Atomizing Nebulizer Shusher Care Shusher Care Atomizer Oto-Tip

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 2015-01-27
KAR Irrigator, Sinus Ear, Nose, Throat Class 1 874.4420 2025-12-23
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2024-12-26
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2015-01-27
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2016-08-25

Official Correspondent

Charlotte Wenham

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

pNeo, LLC
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
K082762 Aardvark Medical AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE 2008-11-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0038-05 Kinetic Concepts, Inc 2
V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011418975. Last updated year: 2026. Please use registration number 3011418975 when referencing this establishment in official correspondence.
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