Cleared Traditional

K955748 - DOYLE EXTRACTOR

K955748 is an FDA 510(k) clearance for DOYLE EXTRACTOR, manufactured by Safetech Intl., Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K955748 · Safetech Intl., Inc. · General Hospital
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Mar 1996
Decision
90d
Days
Class 2
Risk

K955748 is an FDA 510(k) clearance for the DOYLE EXTRACTOR. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Safetech Intl., Inc. (North Attleboro, US). The FDA issued a Cleared decision on March 14, 1996 after a review of 90 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 Safetech Intl., Inc. devices

FDA 510(k) Submission Details - K955748

510(k) Number K955748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1995
Decision Date March 14, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
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 405
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K955748.
RECAP-1
K960641 · Medscience, Inc. · May 1996
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SHARPSPRO-TECTOR
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INSULCAP
K952044 · Karen Holtz · Feb 1996
B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE
K955235 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1996