Cleared Traditional

K770238 - OVERDOSE KIT

K770238 is an FDA 510(k) clearance for OVERDOSE KIT, manufactured by American Hospital Supply Corp.. The device is a Class 2 Toxicology device with product code FMF cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K770238 · American Hospital Supply Corp. · Toxicology device
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Apr 1977
Decision
57d
Days
Class 2
Risk

K770238 is an FDA 510(k) clearance for the OVERDOSE KIT. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1977 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 880.5860 - the FDA toxicology 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 American Hospital Supply Corp. devices

FDA 510(k) Submission Details - K770238

510(k) Number K770238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1977
Decision Date April 05, 1977
Days to Decision 57 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 87d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 373
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K770238.
SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016
K770851 · Concord Laboratories, Inc. · Jul 1977
SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015
K770852 · Concord Laboratories, Inc. · Jul 1977
HYPODERMIC SYRINGE
K771205 · Terumo America, Inc. · Jul 1977
TRAY, BLOOD GAS, CAT. NO. 4010
K770361 · Concord Laboratories, Inc. · Apr 1977
FLUID DISPENSING SYSTEM
K761158 · Pharmaseal Div., Baxter Healthcare Corp. · Jan 1977