Cleared Traditional

K781371 - BONE MARROW ASPIRATION KIT

K781371 is the FDA 510(k) clearance for BONE MARROW ASPIRATION KIT by Ferris Mfg. Corp.. It is a Class 1 General & Plastic Surgery device (product code GAA) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K781371 · Ferris Mfg. Corp. · General & Plastic Surgery device
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Sep 1978
Decision
43d
Days
Class 1
Risk

K781371 is an FDA 510(k) clearance for the BONE MARROW ASPIRATION KIT. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Ferris Mfg. Corp. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1978 after a review of 43 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 Ferris Mfg. Corp. devices

Submission Details

510(k) Number K781371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1978
Decision Date September 20, 1978
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAA Needle, Aspiration And Injection, Disposable
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 - GAA Needle, Aspiration And Injection, Disposable

All 39
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K781371.
NEEDLE II, BURRON FILTER
K790060 · National Patent Development Corp. · Mar 1979
NEEDLE, WITH FILTER
K790142 · National Patent Development Corp. · Feb 1979
NEEDLE, BURRON FILTER
K790061 · National Patent Development Corp. · Feb 1979
CULDOCENTESIS TRAY
K780624 · Cutter Laboratories, Inc. · May 1978
IOPSY TRAY FOR SOFT TISSUE BIOPSY
K771784 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1977
TERUMO DISPOSABLE SPINAL NEEDLE
K760775 · Terumo America, Inc. · Nov 1976