Cleared Traditional

K882114 - AMISCO U-100 INSULIN SYRINGE

K882114 is an FDA 510(k) clearance for AMISCO U-100 INSULIN SYRINGE, manufactured by American Intl. Medical Supply Co.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K882114 · American Intl. Medical Supply Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
97d
Days
Class 2
Risk

K882114 is an FDA 510(k) clearance for the AMISCO U-100 INSULIN SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by American Intl. Medical Supply Co. (Salt Lake City, US). The FDA issued a Cleared decision on August 23, 1988 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all American Intl. Medical Supply Co. devices

FDA 510(k) Submission Details - K882114

510(k) Number K882114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1988
Decision Date August 23, 1988
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 543
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K882114.
MANAN HUBER STYLE INFUSION NEEDLE
K883744 · Manan Medical Products, Inc. · Sep 1988
OPHTHALMIC PAO VALVE
K882536 · Look, Inc. · Sep 1988
BD MICROFINE IV PEN INJECTOR
K881775 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1988
MX350 (SERIES) CONTROL SYRINGE
K883094 · Medex, Inc. · Aug 1988
HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON.
K880963 · Buckman Co., Inc. · Jun 1988
DISPOSABLE SYRINGE
K882335 · Baxter Healthcare Corp · Jun 1988