Cleared Traditional

K811167 - FOCUS STERILE SYRINGES

K811167 is an FDA 510(k) clearance for FOCUS STERILE SYRINGES, manufactured by Stanford Laboratories. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 23-day FDA review.

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

FDA 510(k) Submission Details - K811167

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.

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 546
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K811167.
MONOJECT STERILE M503 3CC SYRINGES
K811505 · Sherwood Medical Co. · Jun 1981
PREFILLED PULSATOR SYRINGE
K811009 · Concord Laboratories, Inc. · Jun 1981
PREFILLED PULSATOR SYRINGE
K810995 · Concord Laboratories, Inc. · May 1981
PISTON SYRINGE
K811065 · Sherwood Medical Co. · May 1981
CONTROL SYRINGE
K801430 · Abco Dealers, Inc. · Jul 1980
BURRON MULTI-AD SYRINGE CAP
K801311 · Burron Medical Products, Inc. · Jun 1980