Cleared Traditional

K802998 - PATIENT CARE DISPOSABLE INFANT SHIRTS

K802998 is the FDA 510(k) clearance for PATIENT CARE DISPOSABLE INFANT SHIRTS by American Convertors Div., American Pharmaseal. It is a Class 1 General Hospital device (product code KME) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K802998 · American Convertors Div., American Pharmaseal · General Hospital
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Dec 1980
Decision
27d
Days
Class 1
Risk

K802998 is an FDA 510(k) clearance for the PATIENT CARE DISPOSABLE INFANT SHIRTS. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by American Convertors Div., American Pharmaseal (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6060 - the FDA general hospital 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 Convertors Div., American Pharmaseal devices

Submission Details

510(k) Number K802998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1980
Decision Date December 22, 1980
Days to Decision 27 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KME Bedding, Disposable, Medical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6060
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KME Bedding, Disposable, Medical

All 18
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K802998.
DISPOSABLE PATIENT BLANKET
K843038 · Anago, Inc. · Oct 1984
3M THINSULATE DISPOSABLE HOSPITAL BED
K820582 · 3M Company · Mar 1982
DISPOSABLE PILLOW
K810264 · Anago, Inc. · Feb 1981
STERILIZATION PROCESS/BABY BLANKET
K792626 · Procter & Gamble Mfg. Co. · Jan 1980
PILLOW, CARTER ARM ELEVATION
K790283 · Depuy, Inc. · Apr 1979
BEDDING, DISPOSABLE HOSPITAL
K781796 · Kimberly-Clark Corp. · Dec 1978