Cleared Special

K071630 - TERUMO 31G THINPRO INSULIN SYRINGE

K071630 is an FDA 510(k) clearance for TERUMO 31G THINPRO INSULIN SYRINGE, manufactured by Terumo Medical Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 27-day FDA review.

K071630 · Terumo Medical Corp. · General Hospital
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Jul 2007
Decision
27d
Days
Class 2
Risk

K071630 is an FDA 510(k) clearance for the TERUMO 31G THINPRO INSULIN SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on July 11, 2007 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Terumo Medical Corp. devices

FDA 510(k) Submission Details - K071630

510(k) Number K071630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2007
Decision Date July 11, 2007
Days to Decision 27 days
Submission Type Special
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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 329
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K071630.
ICU MEDICAL SINGLE-USE SYRINGE
K070856 · Icu Medical, Inc. · Oct 2007
SMALL VOLUME SYRINGE
K062865 · Alcon Laboratories · Aug 2007
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
K071459 · B.Braun Medical, Inc. · Aug 2007
GENIE, MODEL CH-200
K070633 · Icu Medical, Inc. · Jun 2007
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB
K070264 · Terumo Europe N.V. · May 2007
CAPTION APPLICATOR
K063535 · Smith & Nephew, Inc. · Feb 2007