Cleared Traditional

K935776 - SHARPSAFE

K935776 is an FDA 510(k) clearance for SHARPSAFE, manufactured by Smiths Industries Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K935776 · Smiths Industries Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
87d
Days
Class 2
Risk

K935776 is an FDA 510(k) clearance for the SHARPSAFE, CAT. NO. 4126. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Smiths Industries Medical Systems, Inc. (Keene, US). The FDA issued a Cleared decision on February 28, 1994 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Smiths Industries Medical Systems, Inc. devices

FDA 510(k) Submission Details - K935776

510(k) Number K935776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1993
Decision Date February 28, 1994
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 304
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K935776.
BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS
K943594 · Baxter Healthcare Corp · Aug 1994
BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS
K943605 · Baxter Healthcare Corp · Aug 1994
BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
K930217 · Baxter Healthcare Corp · Feb 1994
SHARPSAFE, CAT. NO. 4125
K935777 · Smiths Industries Medical Systems, Inc. · Feb 1994
CLAVE VIAL ACCESS SPIKE
K934591 · Icu Medical, Inc. · Feb 1994
LIFESHIELD BLOOD COLLECTION DEVICE
K933751 · Sherwood Medical Co. · Feb 1994