Cleared Traditional

K100124 - FASTX STERNAL INTRAOSSEOUS DEVICE

K100124 is an FDA 510(k) clearance for FASTX STERNAL INTRAOSSEOUS DEVICE, manufactured by Pyng Medical Corp.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K100124 · Pyng Medical Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
224d
Days
Class 2
Risk

K100124 is an FDA 510(k) clearance for the FASTX STERNAL INTRAOSSEOUS DEVICE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Pyng Medical Corp. (Richmond, Bc, CA). The FDA issued a Cleared decision on August 31, 2010 after a review of 224 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.

FDA 510(k) Submission Details - K100124

510(k) Number K100124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2010
Decision Date August 31, 2010
Days to Decision 224 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 129d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 609
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K100124.
VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET
K102010 · Medpro Safety Products, Inc. · Nov 2010
K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR
K102994 · Kawasumi Laboratories, Inc. · Nov 2010
VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER
K102774 · Greiner Bio-One North America, Inc. · Oct 2010
ZIRCONIA SYRINGE NEEDLE
K093043 · Kuo Tai Hospital Managements & Consultant Co., Ltd. · Aug 2010
POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO
K101026 · Vidacare Corporation · Jul 2010
NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
K093109 · Novo Nordisk, Inc. · Jun 2010
K100124 · FASTX STERNAL INTRAOSSEOUS DEVICE
Download PDF FDA Summary Pyng Medical Corp.