Cleared Traditional

K000144 - NIPRO INSULIN SYRINGE

K000144 is an FDA 510(k) clearance for NIPRO INSULIN SYRINGE, manufactured by Nipro Medical Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K000144 · Nipro Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
24d
Days
Class 2
Risk

K000144 is an FDA 510(k) clearance for the NIPRO INSULIN SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Nipro Medical Corp. (Miami, US). The FDA issued a Cleared decision on February 11, 2000 after a review of 24 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 Nipro Medical Corp. devices

FDA 510(k) Submission Details - K000144

510(k) Number K000144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2000
Decision Date February 11, 2000
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
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 524
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K000144.
ULTICARE DISPOSABLE SYRINGE
K994230 · Ultimed, Inc. · Mar 2000
PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE
K993017 · Shinchang Medical Co., Ltd. · Feb 2000
VEIN ENTRY INDICATOR DEVICE (VEID)
K993995 · Vascular Technologies , Ltd. · Feb 2000
VACLOK SYRINGE
K994253 · Merit Medical Systems, Inc. · Jan 2000
DISETRONIC PEN P100
K993666 · Disetronic Medical Systems · Nov 1999
SEALOUETTE FIBRIN SEALANT APPLICATOR
K992351 · Biosurgical Corp. · Oct 1999