Cleared Traditional

K821348 - HYPODERMIC NEEDLES & SYRINGES

K821348 is the FDA 510(k) clearance for HYPODERMIC NEEDLES & SYRINGES by Medi-Tech, Inc.. It is a Class 1 General & Plastic Surgery device (product code GAA) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K821348 · Medi-Tech, Inc. · General & Plastic Surgery device
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Jun 1982
Decision
36d
Days
Class 1
Risk

K821348 is an FDA 510(k) clearance for the HYPODERMIC NEEDLES & SYRINGES. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Medi-Tech, Inc. (Walker, US). The FDA issued a Cleared decision on June 10, 1982 after a review of 36 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 Medi-Tech, Inc. devices

Submission Details

510(k) Number K821348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1982
Decision Date June 10, 1982
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
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 11
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K821348.
GILL'S IRRIGATOR/ASPIRATOR NEEDLE
K843925 · Concept, Inc. · Nov 1984
TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709
K831392 · Travenol Laboratories, S.A. · Jul 1983
STERILE, DISPOSABLE, HYPODERMIC NEEDLES
K830378 · Abco Dealers, Inc. · Mar 1983
ACCU-CORE DISPOSABLE BIOPSY NEEDLE
K801457 · Medline Industries, Inc. · Jul 1980
IOPSY TRAY FOR SOFT TISSUE BIOPSY
K771784 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1977