Cleared Traditional

K874186 - BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE

K874186 · Busse Hospital Disposables, Inc. · General & Plastic Surgery device
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Dec 1987
Decision
76d
Days
-
Risk

K874186 is an FDA 510(k) clearance for the BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE.

Submitted by Busse Hospital Disposables, Inc. (Hauppauge, US). The FDA issued a Cleared decision on December 29, 1987 after a review of 76 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.

FDA 510(k) Submission Details - K874186

510(k) Number K874186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1987
Decision Date December 29, 1987
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 80
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K874186.
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K882388 · Burney Products Corp. · Jul 1988
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K880048 · Crescent Corp. · Mar 1988
STERILABELS
K864015 · Diversatronics, Inc. · Dec 1986
SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES
K863633 · Biological & Environmental Control Laboratories · Oct 1986
STUART GILMAN'S WEIGHT LOSS PLAN
K854441 · Alpha Therapeutic Corp. · Feb 1986
K874186 · BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE
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