Cleared Traditional

K811065 - PISTON SYRINGE

K811065 is an FDA 510(k) clearance for PISTON SYRINGE, manufactured by Sherwood Medical Co.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K811065 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1981
Decision
18d
Days
Class 2
Risk

K811065 is an FDA 510(k) clearance for the PISTON SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Walker, US). The FDA issued a Cleared decision on May 5, 1981 after a review of 18 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.

FDA 510(k) Submission Details - K811065

510(k) Number K811065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1981
Decision Date May 05, 1981
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
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 755
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K811065.
PREFILLED PULSATOR SYRINGE
K811009 · Concord Laboratories, Inc. · Jun 1981
PREFILLED PULSATOR SYRINGE
K810995 · Concord Laboratories, Inc. · May 1981
FOCUS STERILE SYRINGES
K811167 · Stanford Laboratories · May 1981
PREHEPARINZED SYRINGE
K803302 · The University of Chicago · Apr 1981
IRRIGATION PISTON
K803204 · Walpak Co. · Jan 1981
CYTOTRAN I BONE MARROW ASPIRATION SYSTEM
K802406 · Applied Medical Devices, Inc. · Jan 1981
K811065 · PISTON SYRINGE
Download PDF Sherwood Medical Co.