Cleared Traditional

K901995 - PLEURA BIOPSY DEVICE

K901995 is an FDA 510(k) clearance for PLEURA BIOPSY DEVICE, manufactured by Mill-Rose Laboratory. The device is a Class 1 General & Plastic Surgery device with product code GDM cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K901995 · Mill-Rose Laboratory · General & Plastic Surgery device
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Jul 1990
Decision
69d
Days
Class 1
Risk

K901995 is an FDA 510(k) clearance for the PLEURA BIOPSY DEVICE. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on July 10, 1990 after a review of 69 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.

FDA 510(k) Submission Details - K901995

510(k) Number K901995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1990
Decision Date July 10, 1990
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

GDM Device Classification - Class 1, General Controls

Product Code GDM Needle, Aspiration And Injection, Reusable
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 - GDM Needle, Aspiration And Injection, Reusable

All 47
Devices cleared under the same product code (GDM) and FDA review panel - the closest regulatory comparables to K901995.
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U
K903749 · Downs Surgical , Ltd. · Oct 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E
K903750 · Downs Surgical , Ltd. · Oct 1990
MANAN BONE BIOPSY NEEDLE
K902177 · Manan Medical Products, Inc. · Sep 1990
DIAMOND BLADE SURGICAL KNIVES
K895752 · Magnum Diamond, Inc. · Oct 1989
ROCKET BONE MARROW NEEDLE
K895551 · A & A Medical, Inc. · Oct 1989
SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE
K895594 · Go Medical Industries Pty. , Ltd. · Oct 1989
K901995 · PLEURA BIOPSY DEVICE
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