Cleared Traditional

K972877 - ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD

K972877 is an FDA 510(k) clearance for ULTRASAFE INJECTION SYSTEM MODEL C200 I..., manufactured by Safety Syringes, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K972877 · Safety Syringes, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
206d
Days
Class 2
Risk

K972877 is an FDA 510(k) clearance for the ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Safety Syringes, Inc. (Arcadia, US). The FDA issued a Cleared decision on February 26, 1998 after a review of 206 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Safety Syringes, Inc. devices

FDA 510(k) Submission Details - K972877

510(k) Number K972877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1997
Decision Date February 26, 1998
Days to Decision 206 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
77d slower than avg
Panel avg: 129d · This submission: 206d
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 416
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K972877.
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B-D E ML PEN
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TERUMO ALLERGY SYRINGE
K980796 · Terumo Corp. · Apr 1998
ULTRASAFE MODEL T200 INJECTOR
K972900 · Safety Syringes, Inc. · Feb 1998
DAXOR MAX100 SYRINGE (MAX100)
K970419 · Daxor Corporation · Dec 1997
DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)
K973510 · Immuno-U.S., Inc. · Dec 1997