Cleared Traditional

K251664 - Single Use Aspiration Needle (NA-201SX-4021) (FDA 510(k) Clearance)

Also includes:
Single Use Aspiration Needle (NA-201SX-4022)

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

K251664 · Olympus Medical Systems Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
60d
Days
Class 2
Risk

K251664 is an FDA 510(k) clearance for the Single Use Aspiration Needle (NA-201SX-4021). Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Hachioji-Shi, JP). The FDA issued a Cleared decision on July 29, 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 K251664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2025
Decision Date July 29, 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 KTI Bronchoscope Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition 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 Peers - KTI Bronchoscope Accessory

All 32
Devices cleared under the same product code (KTI) and FDA review panel - the closest regulatory comparables to K251664.
ClearTip TBNA Type
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K251402 · Leadoptik, Inc. · Dec 2025
Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
K252874 · Serpex Medical, Inc. · Oct 2025
Disposable Grasping Forceps FG-52D/FG-54D
K250263 · Olympus Medical Systems Corp. · Mar 2025
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K241679 · Alton (Shanghai) Medical Instruments Co., Ltd. · Mar 2025