Cleared Traditional

K896086 - PROGUARD II(TM)

K896086 is an FDA 510(k) clearance for PROGUARD II(TM), manufactured by Safety-Ject, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K896086 · Safety-Ject, Inc. · General Hospital
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Jan 1990
Decision
97d
Days
Class 2
Risk

K896086 is an FDA 510(k) clearance for the PROGUARD II(TM). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Safety-Ject, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on January 24, 1990 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Safety-Ject, Inc. devices

FDA 510(k) Submission Details - K896086

510(k) Number K896086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1989
Decision Date January 24, 1990
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
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 522
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K896086.
JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR
K902157 · Johnson & Johnson Medical, Inc. · Nov 1990
DISPOSABLE CORONARY CONTROL SYRINGE
K902346 · Advance Medical Designs, Inc. · Jun 1990
AUTOPEN
K895890 · Ulster Scientific, Inc. · Feb 1990
INTOPO
K894206 · Acacia, Inc. · Oct 1989
30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES
K894801 · Advance Medical Designs, Inc. · Sep 1989
NEEDLE*LESS DRUG VIAL ADAPTER
K894177 · Baxter Healthcare Corp · Sep 1989