Cleared Traditional

FOCUS STERILE SYRINGES (K811167) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K811167 · Stanford Laboratories · General Hospital
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May 1981
Decision
23d
Days
Class 2
Risk

K811167 is an FDA 510(k) clearance for the FOCUS STERILE SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Stanford Laboratories (Mchenry, US). The FDA issued a Cleared decision on May 21, 1981 after a review of 23 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 Stanford Laboratories devices

Submission Details

510(k) Number K811167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1981
Decision Date May 21, 1981
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 240
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K811167.
MONOJECT M535 35CC SYRINGE
K812748 · Sherwood Medical Co. · Oct 1981
MONOJECT STERILE M506 6CC SYRINGES
K812023 · Sherwood Medical Co. · Jul 1981
MONOJECT STERILE M503 3CC SYRINGES
K811505 · Sherwood Medical Co. · Jun 1981
PISTON SYRINGE
K811065 · Sherwood Medical Co. · May 1981
CONTROL SYRINGE
K801430 · Abco Dealers, Inc. · Jul 1980
DYNACOR STERILE BLOOD GAS SPECIMEN TRAY
K792033 · Medline Industries, Inc. · Nov 1979