Cleared Traditional

K771888 - SYRINGE

K771888 is an FDA 510(k) clearance for SYRINGE, manufactured by Orthopedic Equipment Co., Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K771888 · Orthopedic Equipment Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1977
Decision
16d
Days
Class 2
Risk

K771888 is an FDA 510(k) clearance for the SYRINGE, DISPOSABLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Orthopedic Equipment Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 21, 1977 after a review of 16 days - a notably fast clearance 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: 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 Orthopedic Equipment Co., Inc. devices

FDA 510(k) Submission Details - K771888

510(k) Number K771888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1977
Decision Date October 21, 1977
Days to Decision 16 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 129d · This submission: 16d
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 329
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K771888.
IRRIGATION TRAY
K780600 · Abco Dealers, Inc. · Apr 1978
SYRINGE (IRRIGATION)
K780602 · Abco Dealers, Inc. · Apr 1978
SYRINGE, BLOOD, SAMPLING, ARTERIAL
K772338 · C.R. Bard, Inc. · Jan 1978
ARTEOIAL BLOOD SAMPLING KIT 2D9014
K771584 · Travenol Laboratories, S.A. · Sep 1977
ALLERGIST PACK SYRINGES
K771359 · Pharmaseal Div., Baxter Healthcare Corp. · Aug 1977
TRAY, BLOOD GAS, ARTERIAL, #4014
K770850 · Concord Laboratories, Inc. · Jul 1977