Cleared Traditional

K973254 - J-TIP INJECTOR

K973254 is an FDA 510(k) clearance for J-TIP INJECTOR, manufactured by National Medical Products, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K973254 · National Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
87d
Days
Class 2
Risk

K973254 is an FDA 510(k) clearance for the J-TIP INJECTOR. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by National Medical Products, Inc. (Irvine, US). The FDA issued a Cleared decision on November 24, 1997 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5430 - 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.

FDA 510(k) Submission Details - K973254

510(k) Number K973254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1997
Decision Date November 24, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZE Device Classification - Class 2, Special Controls

Product Code KZE Injector, Fluid, Non-electrically Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5430
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 - KZE Injector, Fluid, Non-electrically Powered

All 42
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K973254.
CLICKER
K994384 · Bioject, Inc. · Jun 2000
MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
K991294 · Medi-Ject Corp. · Apr 1999
J-TIP NEEDLESS INJECTOR
K980082 · National Medical Products, Inc. · Mar 1998
BIOJECTOR 2000 MODEL 1B02000
K960373 · Bioject, Inc. · Mar 1997
VITAJET
K962625 · Vitajet Corp. · Dec 1996
MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
K962956 · Medi-Ject Corp. · Oct 1996
K973254 · J-TIP INJECTOR
Download PDF National Medical Prod…