Cleared Traditional

K964042 - EXTRESAFE PHLEBOTOMY

K964042 is an FDA 510(k) clearance for EXTRESAFE PHLEBOTOMY, manufactured by Specialized Health Products, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K964042 · Specialized Health Products, Inc. · General Hospital
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Jun 1997
Decision
241d
Days
Class 2
Risk

K964042 is an FDA 510(k) clearance for the EXTRESAFE PHLEBOTOMY. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Specialized Health Products, Inc. (Sandy, US). The FDA issued a Cleared decision on June 6, 1997 after a review of 241 days - an extended review 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: 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 Specialized Health Products, Inc. devices

FDA 510(k) Submission Details - K964042

510(k) Number K964042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1996
Decision Date June 06, 1997
Days to Decision 241 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 129d · This submission: 241d
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 539
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K964042.
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