Cleared Traditional

K070917 - FEEL-JECT INSULIN SYRINGE

K070917 is an FDA 510(k) clearance for FEEL-JECT INSULIN SYRINGE, manufactured by Feel Tech. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K070917 · Feel Tech · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
79d
Days
Class 2
Risk

K070917 is an FDA 510(k) clearance for the FEEL-JECT INSULIN SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Feel Tech (Deer Field, US). The FDA issued a Cleared decision on June 20, 2007 after a review of 79 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 Feel Tech devices

FDA 510(k) Submission Details - K070917

510(k) Number K070917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2007
Decision Date June 20, 2007
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 129d · This submission: 79d
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 373
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K070917.
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
TERUMO 31G THINPRO INSULIN SYRINGE
K071630 · Terumo Medical Corp. · Jul 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