Cleared Traditional

THE HAMMER MODEL H100 (K012041) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012041 · Tenacore Holdings, Inc. · Cardiovascular device
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Mar 2002
Decision
272d
Days
Class 2
Risk

K012041 is an FDA 510(k) clearance for the THE HAMMER MODEL H100. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Tenacore Holdings, Inc. (Mission Viejo,, US). The FDA issued a Cleared decision on March 28, 2002 after a review of 272 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Tenacore Holdings, Inc. devices

Submission Details

510(k) Number K012041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2001
Decision Date March 28, 2002
Days to Decision 272 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 125d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 40
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K012041.
TR BAND
K070423 · Terumo Medical Corp. · Mar 2007
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
K062569 · Datascope Corp. · Feb 2007
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
K014277 · KARL STORZ Endoscopy-America, Inc. · Dec 2002
KSEA DION-GRACIA SET
K010785 · KARL STORZ Endoscopy-America, Inc. · Aug 2001
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc. · Jan 2000
OCCLUSION CLAMP** DEVICE
K964251 · United States Surgical, A Division of Tyco Healthc · May 1997