Cleared Traditional

K951051 - RITE-BITE BIOPSY FORCEPS

K951051 is the FDA 510(k) clearance for RITE-BITE BIOPSY FORCEPS by Mill-Rose Laboratory. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K951051 · Mill-Rose Laboratory · Ear, Nose, Throat device
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Mar 1995
Decision
18d
Days
Class 2
Risk

K951051 is an FDA 510(k) clearance for the RITE-BITE BIOPSY FORCEPS. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat 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 Mill-Rose Laboratory devices

Submission Details

510(k) Number K951051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1995
Decision Date March 24, 1995
Days to Decision 18 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 89d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 177
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K951051.
KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE
K951826 · KARL STORZ Endoscopy-America, Inc. · May 1995
FB-18X, FIBER BRONCHOSCOPE
K951199 · Pentax Precision Instrument Corp. · Apr 1995
KARL STORZ STENT APPLICATOR FORCEPS
K950965 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
OLYMPUS BIOPSY FORCEPS MODEL FB-44
K950786 · Olympus America, Inc. · Mar 1995
OLYMPUS DISPOSABLE BIOPSY FORCEPS
K950636 · Olympus America, Inc. · Feb 1995
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE
K931442 · KARL STORZ Endoscopy-America, Inc. · Jan 1995