Cleared Traditional

K822650 - SUPER DONUT

K822650 is an FDA 510(k) clearance for SUPER DONUT, manufactured by Alimed, Inc.. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K822650 · Alimed, Inc. · General Hospital
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Sep 1982
Decision
28d
Days
Class 1
Risk

K822650 is an FDA 510(k) clearance for the SUPER DONUT. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Alimed, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1982 after a review of 28 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 Alimed, Inc. devices

FDA 510(k) Submission Details - K822650

510(k) Number K822650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1982
Decision Date September 30, 1982
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

KME Device Classification - Class 1, General Controls

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 25
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K822650.
DISPOSABLE PATIENT BLANKET
K843038 · Anago, Inc. · Oct 1984
PILLOW COVER, ANTI-MICROBIAL
K832486 · American Threshold Industries, Inc. · Feb 1984
DRAW SHEET, ANTI-MICROBIAL
K832487 · American Threshold Industries, Inc. · Feb 1984
3M THINSULATE DISPOSABLE HOSPITAL BED
K820582 · 3M Company · Mar 1982
PATIENT UNDERPAD
K813263 · The Buckeye Cellulose Corp. · Nov 1981
DISPOSABLE PILLOW
K810264 · Anago, Inc. · Feb 1981