Cleared Traditional

K953626 - SYRINGE MAGNIFIER

K953626 is an FDA 510(k) clearance for SYRINGE MAGNIFIER, manufactured by Innovative Premiums, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K953626 · Innovative Premiums, Inc. · General Hospital
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Dec 1995
Decision
121d
Days
Class 2
Risk

K953626 is an FDA 510(k) clearance for the SYRINGE MAGNIFIER. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Innovative Premiums, Inc. (Oceanside, US). The FDA issued a Cleared decision on December 1, 1995 after a review of 121 days - within the typical 510(k) review window.

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 Innovative Premiums, Inc. devices

FDA 510(k) Submission Details - K953626

510(k) Number K953626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1995
Decision Date December 01, 1995
Days to Decision 121 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 129d · This submission: 121d
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 535
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K953626.
GENERAL PROCEDURE KIT
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UNIQUE NEEDLE WITH FIRM GRIP SHIELD
K950666 · Unique Management Ent., Inc. · Feb 1996
BECTON DICKINSON SYRINGSE
K954064 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1995
GENOTROPIN MIXER
K954337 · Pharmacia, Inc. · Nov 1995
B-D PEN ULTRA
K951919 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1995