Cleared Traditional

K854541 - TIP OFF FORCEPS

K854541 is the FDA 510(k) clearance for TIP OFF FORCEPS by Keller Instruments, Inc.. It is a Class 1 General & Plastic Surgery device (product code GEN) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K854541 · Keller Instruments, Inc. · General & Plastic Surgery device
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Dec 1985
Decision
34d
Days
Class 1
Risk

K854541 is an FDA 510(k) clearance for the TIP OFF FORCEPS. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Keller Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on December 17, 1985 after a review of 34 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 Keller Instruments, Inc. devices

Submission Details

510(k) Number K854541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1985
Decision Date December 17, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEN Forceps, General & Plastic Surgery
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 - GEN Forceps, General & Plastic Surgery

All 54
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K854541.
TISSUE FORCEPS, VARIOUS TYPES
K891896 · Zinnanti Surgical Instruments, Inc. · Apr 1989
HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT
K891401 · Zinnanti Surgical Instruments, Inc. · Apr 1989
PILLING HEMOSTATIC CLIP APPLIER FORCEPS
K854916 · Pilling Co. · Jan 1986
SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420
K853015 · The Huxley Instrument Corp. · Jul 1985
IRIS FORCEPS, DELICATE, 1X2 TEETH, STRAIGHT, 4XSS
K852717 · The Huxley Instrument Corp. · Jul 1985
CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420
K852730 · The Huxley Instrument Corp. · Jul 1985