Cleared Traditional

K780488 - INSTRUMENT AND ACCESSORY KIT

K780488 is an FDA 510(k) clearance for INSTRUMENT AND ACCESSORY KIT, manufactured by American Hospital Supply Corp.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K780488 · American Hospital Supply Corp. · General & Plastic Surgery device
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Apr 1978
Decision
16d
Days
Class 1
Risk

K780488 is an FDA 510(k) clearance for the INSTRUMENT AND ACCESSORY KIT. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1978 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Hospital Supply Corp. devices

FDA 510(k) Submission Details - K780488

510(k) Number K780488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1978
Decision Date April 12, 1978
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

KDD Device Classification - Class 1, General Controls

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - KDD Kit, Surgical Instrument, Disposable

All 29
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K780488.
EMERGENCY DEPARTMENT LACERATION KIT-
K802557 · Johnson & Johnson Professionals, Inc. · Nov 1980
DRESSING CHANGE SET CAT.#910-930
K802017 · Pollak (Intl.), Ltd. · Oct 1980
SUTURE REMOVAL SET CAT.#906
K802019 · Pollak (Intl.), Ltd. · Sep 1980
URINE SAMPLE KIT
K780336 · American Hospital Supply Corp. · Apr 1978
MAJOR SUTURE REMOVAL TRAY
K770149 · Pharmaseal Div., Baxter Healthcare Corp. · Feb 1977