Cleared Traditional

CRILE, CURVED FORCEPS 5 1/2 (K821281) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K821281 · Conphar, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1982
Decision
24d
Days
Class 1
Risk

K821281 is an FDA 510(k) clearance for the CRILE, CURVED FORCEPS 5 1/2. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1982 after a review of 24 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 Conphar, Inc. devices

Submission Details

510(k) Number K821281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1982
Decision Date May 27, 1982
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 21
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K821281.
HARTMAN FORCEPS STRAIGHT 3 1/2
K821278 · Conphar, Inc. · May 1982
HALSTEAD FORCEPS (MOSQUITO) 5
K821279 · Conphar, Inc. · May 1982
TISSUE FORCEPS
K821280 · Conphar, Inc. · May 1982
HARTMAN FORCEPS (MOSQUITO)
K821283 · Conphar, Inc. · May 1982
CRILE FORCEPS STRAIGHT 5 1/2
K821287 · Conphar, Inc. · May 1982
ROCHESTER PEAN FORCEPS CURVED 6 1/4
K821296 · Conphar, Inc. · May 1982