Cleared Traditional

K881791 - STERA DISPOSABLE SYRINGES

K881791 is an FDA 510(k) clearance for STERA DISPOSABLE SYRINGES, manufactured by Excel U.S.A.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K881791 · Excel U.S.A. · General Hospital
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Dec 1988
Decision
240d
Days
Class 2
Risk

K881791 is an FDA 510(k) clearance for the STERA DISPOSABLE SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Excel U.S.A. (West Covina, US). The FDA issued a Cleared decision on December 22, 1988 after a review of 240 days - an extended review cycle.

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 Excel U.S.A. devices

FDA 510(k) Submission Details - K881791

510(k) Number K881791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1988
Decision Date December 22, 1988
Days to Decision 240 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
111d slower than avg
Panel avg: 129d · This submission: 240d
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 514
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K881791.
SYRINGE TIP ADAPTOR
K894217 · Acacia, Inc. · Sep 1989
MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR
K894335 · Midmark Corp. · Sep 1989
DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN
K890082 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1989
CONTROL SYRINGE
K884497 · Professional Medical Services · Dec 1988
SINGLE-FIL(TM) SYRINGE
K883955 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
MANAN HUBER STYLE INFUSION NEEDLE
K883744 · Manan Medical Products, Inc. · Sep 1988