Cleared Traditional

K994151 - PERCUTX-INJECTION/ASPIRATION NEEDLE PRO...

K994151 is an FDA 510(k) clearance for PERCUTX-INJECTION/ASPIRATION NEEDLE PRO..., manufactured by Ximed/Prosure/Injectx. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K994151 · Ximed/Prosure/Injectx · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
83d
Days
Class 1
Risk

K994151 is an FDA 510(k) clearance for the PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Ximed/Prosure/Injectx (San Jose, US). The FDA issued a Cleared decision on March 1, 2000 after a review of 83 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 Ximed/Prosure/Injectx devices

FDA 510(k) Submission Details - K994151

510(k) Number K994151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1999
Decision Date March 01, 2000
Days to Decision 83 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 115d · This submission: 83d
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 42
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K994151.
CapnoSpot™ Pneumothorax Decompression Indicator
K223625 · Pneumeric, Inc. · Mar 2023
MANAN ACCURA NEEDLE
K974741 · Medical Device Technologies, Inc. · Jan 1998
MD TECH BIOPSY SET FOR BONE AND BONE MARROW
K961959 · Medical Device Technologies, Inc. · Jul 1996
MONOJECT BONE MARROW BIOPSY TRAYS
K945109 · Sherwood Medical Co. · Nov 1994
MANAN GENERAL PURPOSE INTRODUCER NEEDLE
K940024 · Manan Medical Products, Inc. · Feb 1994
MANAN BONE MARROW HARVEST NEEDLES
K940025 · Manan Medical Products, Inc. · Feb 1994