Cleared Traditional

K250957 - Disposable Biopsy Forceps (FB-211D) (FDA 510(k) Clearance)

Also includes:
Disposable Biopsy Forceps (FB-221D) Disposable Biopsy Forceps (FB-231D) Disposable Biopsy Forceps (FB-241D)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250957 · Olympus Medical Systems Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
60d
Days
Class 2
Risk

K250957 is an FDA 510(k) clearance for the Disposable Biopsy Forceps (FB-211D). Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Tokyo, JP). The FDA issued a Cleared decision on May 30, 2025 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4680 - the FDA anesthesiology and respiratory 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 Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K250957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2025
Decision Date May 30, 2025
Days to Decision 60 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 139d · This submission: 60d
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 Anesthesiology devices follow this clearance model.

Regulatory Consultant

Olympus Surgical Techologies of America
Susan Lewandowski

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 236
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K250957.
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190)
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