Cleared Traditional

K961309 - POS-T-VAC ID-300

K961309 is an FDA 510(k) clearance for POS-T-VAC ID-300, manufactured by Pos-T-Vac, Inc.. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K961309 · Pos-T-Vac, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
67d
Days
Class 2
Risk

K961309 is an FDA 510(k) clearance for the POS-T-VAC ID-300. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Pos-T-Vac, Inc. (Washington, US). The FDA issued a Cleared decision on June 10, 1996 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6920 - 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 Pos-T-Vac, Inc. devices

FDA 510(k) Submission Details - K961309

510(k) Number K961309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1996
Decision Date June 10, 1996
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZH Device Classification - Class 2, Special Controls

Product Code KZH Introducer, Syringe Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6920
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 - KZH Introducer, Syringe Needle

All 9
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K961309.
QUICK-SERTER, MODEL 395
K992300 · Medtronic Minimed · Jul 1999
B-D AUTO-INJECTOR
K974678 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1998
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
K970479 · Medtronic Minimed · Mar 1997
V-CATH PERCUTANEOUS INTRODUCER KIT
K951384 · Hdc Corp. · Jun 1995
V-CATH BREAKAWAY NEEDLE INTRODUCER
K945473 · Hdc Corp. · Jan 1995
MONOJECT INJECTOMATIC
K832683 · Sherwood Medical Co. · Sep 1983