Cleared Traditional

K822443 - NASO-GARD NASOGASTRIC TUBE HOLDER

K822443 is an FDA 510(k) clearance for NASO-GARD NASOGASTRIC TUBE HOLDER, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K822443 · American Pharmaseal Div. Ahsc · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1982
Decision
17d
Days
Class 2
Risk

K822443 is an FDA 510(k) clearance for the NASO-GARD NASOGASTRIC TUBE HOLDER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Mchenry, US). The FDA issued a Cleared decision on September 2, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K822443

510(k) Number K822443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1982
Decision Date September 02, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 344
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K822443.
PEDI-TUBE PEDIATRIC FEEDING TUBE
K822875 · Biosearch Medical Products, Inc. · Oct 1982
GASTRO VAGE SET FOR GASTRIC LAVAGE
K822228 · Ackrad Laboratories · Sep 1982
ARGYLE DUO-TUBE
K822631 · Sherwood Medical Co. · Sep 1982
CONPHAR SILICONE FEEDING TUBE
K821825 · Conphar, Inc. · Aug 1982
AM. PH. STERILE FEEDING TUBE
K820420 · American Pharmaseal Div. Ahsc · Mar 1982
ARGYLE PVC FEEDING TUBE
K820441 · Sherwood Medical Co. · Mar 1982