Cleared Traditional

K874602 - ASD-BIO ANTI-STICK DEVICE

K874602 is an FDA 510(k) clearance for ASD-BIO ANTI-STICK DEVICE, manufactured by Biosurge, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K874602 · Biosurge, Inc. · General Hospital
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Feb 1988
Decision
102d
Days
Class 2
Risk

K874602 is an FDA 510(k) clearance for the ASD-BIO ANTI-STICK DEVICE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Biosurge, Inc. (Rochester, US). The FDA issued a Cleared decision on February 19, 1988 after a review of 102 days - within the typical 510(k) review window.

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: 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 Biosurge, Inc. devices

FDA 510(k) Submission Details - K874602

510(k) Number K874602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date February 19, 1988
Days to Decision 102 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
27d faster than avg
Panel avg: 129d · This submission: 102d
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 522
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K874602.
NON-CORING NEEDLES
K883009 · Quinton, Inc. · Oct 1988
VIGGO VASCUPORT NEEDLE
K881758 · Ohmeda Medical · Jun 1988
BLOOD COLLECTING NEEDLE AND HOLDERS
K880892 · Abco Dealers, Inc. · Apr 1988
CHEMO-PORT NON-CORING NEEDLES
K873165 · Hdc Corp. · Dec 1987
HR(TM) NEEDLE AND SYRINGE
K874372 · Icu Medical, Inc. · Nov 1987
BLOOD NEEDLE HOLDER
K873569 · Sage Products, Inc. · Nov 1987