Cleared Traditional

K101547 - HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)

K101547 is an FDA 510(k) clearance for HENKE- SASS, manufactured by Henke-Sass, Wolf GmbH. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K101547 · Henke-Sass, Wolf GmbH · General Hospital
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Nov 2010
Decision
172d
Days
Class 2
Risk

K101547 is an FDA 510(k) clearance for the HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Henke-Sass, Wolf GmbH (Mount Dora, US). The FDA issued a Cleared decision on November 22, 2010 after a review of 172 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Henke-Sass, Wolf GmbH devices

FDA 510(k) Submission Details - K101547

510(k) Number K101547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2010
Decision Date November 22, 2010
Days to Decision 172 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 129d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 565
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K101547.
PATIENT SAFE LUER CAP
K101708 · Retractable Technologies, Inc. · Feb 2011
INDISCAL DIGITAL MANOMETER
K102192 · Baylis Medical Co., Inc. · Feb 2011
IMC PISTON SYRINGES
K102969 · International Medsurg Connection · Dec 2010
EASY TOUCH
K102178 · Mhc Medical Products · Sep 2010
INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)
K101359 · Inviro Medical Devices, Inc. · Aug 2010
HUMAPEN LUXURA HD
K100988 · Eli Lilly and Company · Aug 2010