Cleared Traditional

K821396 - OUT-RITE WASTE DISPOSABLE BAG

K821396 · Kleen Test Products · General & Plastic Surgery device
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Jun 1982
Decision
29d
Days
-
Risk

K821396 is an FDA 510(k) clearance for the OUT-RITE WASTE DISPOSABLE BAG.

Submitted by Kleen Test Products (Mchenry, US). The FDA issued a Cleared decision on June 9, 1982 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

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FDA 510(k) Submission Details - K821396

510(k) Number K821396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1982
Decision Date June 09, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 36
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K821396.
TOURNIQUET CUFF PRESSURE MONITOR #TCPM
K832272 · Electromedics, Inc. · Nov 1983
PLASTIC DISPOSABLE RAZOR
K831799 · I M, Inc. · Jul 1983
INFECTION CONTROL TOWEL
K822484 · American Threshold Industries, Inc. · Sep 1982
SAFETY PINS
K820052 · Stan-Pak Ent. · Feb 1982
TRACHEOSTOMY CARE TRAY
K813260 · E.M. Adams · Dec 1981
POSTURE MIRROR
K812479 · Maddak, Inc. · Dec 1981