Cleared Traditional

K895024 - PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE

K895024 is an FDA 510(k) clearance for PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE, manufactured by Bio-Plexus, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 409-day FDA review.

K895024 · Bio-Plexus, Inc. · General Hospital
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Sep 1990
Decision
409d
Days
Class 2
Risk

K895024 is an FDA 510(k) clearance for the PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Bio-Plexus, Inc. (Tolland, US). The FDA issued a Cleared decision on September 21, 1990 after a review of 409 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Bio-Plexus, Inc. devices

FDA 510(k) Submission Details - K895024

510(k) Number K895024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date September 21, 1990
Days to Decision 409 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
280d slower than avg
Panel avg: 129d · This submission: 409d
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 443
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K895024.
SAFETY NEEDLE SHEATH, MODIFICATION
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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