Cleared Traditional

K032091 - SMART KLAMP VARIOUS BY SIZE

K032091 is an FDA 510(k) clearance for SMART KLAMP VARIOUS BY SIZE, manufactured by Emergogroup, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFX cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K032091 · Emergogroup, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
245d
Days
Class 2
Risk

K032091 is an FDA 510(k) clearance for the SMART KLAMP VARIOUS BY SIZE. Classified as Clamp, Circumcision (product code HFX), Class II - Special Controls.

Submitted by Emergogroup, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 8, 2004 after a review of 245 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K032091

510(k) Number K032091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2003
Decision Date March 08, 2004
Days to Decision 245 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 161d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFX Device Classification - Class 2, Special Controls

Product Code HFX Clamp, Circumcision
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HFX Clamp, Circumcision

All 26
Devices cleared under the same product code (HFX) and FDA review panel - the closest regulatory comparables to K032091.
GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200
K063429 · Generic Medical Device, Inc. · Jan 2007
SURGICAL DESIGN CIRCUMCISION CLAMP
K043533 · Surgical Design, Inc. · Apr 2005
FINE SURGICAL CIRCUMCISION CLAMP
K040052 · Fine Surgical Instrument Corp. · Apr 2004
T.S. MEDICAL CIRCUMCISION CLAMP
K033403 · T.S. Medical · Jan 2004
KILEJIAN CIRCUMCISOR
K010867 · Iris Surgical, LLC · May 2001
CIRCUMCISION TRAY, CAT. NO. 70340
K974286 · Trinity Laboratories, Inc. · Dec 1997
K032091 · SMART KLAMP VARIOUS BY SIZE
Download PDF FDA Summary Emergogroup, Inc.