Cleared Traditional

K904295 - PROGUARD(TM) BLOOD COLLECTION NEEDLE

K904295 is an FDA 510(k) clearance for PROGUARD(TM) BLOOD COLLECTION NEEDLE, manufactured by Safety-Ject, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K904295 · Safety-Ject, Inc. · General Hospital
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Oct 1990
Decision
26d
Days
Class 2
Risk

K904295 is an FDA 510(k) clearance for the PROGUARD(TM) BLOOD COLLECTION NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Safety-Ject, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on October 15, 1990 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Safety-Ject, Inc. devices

FDA 510(k) Submission Details - K904295

510(k) Number K904295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1990
Decision Date October 15, 1990
Days to Decision 26 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
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 488
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K904295.
SAFETY NEEDLE SHEATH, MODIFICATION
K911037 · Concord/Portex · May 1991
VIAL ACCESS CANNULA
K905664 · Baxter Healthcare Corp · Mar 1991
SAFETY NEEDLE SHEATH
K904198 · Concord/Portex · Dec 1990
EXEL HUBER NEEDLE
K895769 · Exel Intl. · Feb 1990
EXEL SPINAL NEEDLES
K895771 · Exel Intl. · Feb 1990
B-D PEND NEEDLE
K895630 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989