Cleared Traditional

K810248 - MSI BONE MARROW BIOPSY NEEDLE W/J TIP

K810248 is an FDA 510(k) clearance for MSI BONE MARROW BIOPSY NEEDLE W/J TIP, manufactured by Creative Research and Mfg., Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K810248 · Creative Research and Mfg., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1981
Decision
50d
Days
Class 1
Risk

K810248 is an FDA 510(k) clearance for the MSI BONE MARROW BIOPSY NEEDLE W/J TIP. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Creative Research and Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 20, 1981 after a review of 50 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 Creative Research and Mfg., Inc. devices

FDA 510(k) Submission Details - K810248

510(k) Number K810248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1981
Decision Date March 20, 1981
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

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 75
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K810248.
HYPODERMIC NEEDLES & SYRINGES
K821348 · Medi-Tech, Inc. · Jun 1982
CUATICO MYELOGRAPHY NEEDLES
K813367 · Dlp, Inc. · Jan 1982
DISPOSABLE CHIBA-TYPE NEEDLE
K813368 · Dlp, Inc. · Jan 1982
PHERESIS NEEDLE ASSEMBLY
K810076 · Haemonetics Corp. · Mar 1981
ADT BONE MARROW BIOPSY-ASPIR. NEELDE
K801753 · A.D.T. Lab Industries · Aug 1980
ADT BONE MARROW ASPIRATION NEEDLE
K801754 · A.D.T. Lab Industries · Aug 1980