Cleared Traditional

K010695 - KOALA CLAMP

K010695 is an FDA 510(k) clearance for KOALA CLAMP, manufactured by Maternus, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K010695 · Maternus, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
56d
Days
Class 2
Risk

K010695 is an FDA 510(k) clearance for the KOALA CLAMP. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by Maternus, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 3, 2001 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Maternus, Inc. devices

FDA 510(k) Submission Details - K010695

510(k) Number K010695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2001
Decision Date May 03, 2001
Days to Decision 56 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 160d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFW Device Classification - Class 2, Special Controls

Product Code HFW Clamp, Umbilical
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 - HFW Clamp, Umbilical

All 19
Devices cleared under the same product code (HFW) and FDA review panel - the closest regulatory comparables to K010695.
SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
K020718 · Precision Dynamics Corp. · Jun 2002
BUSSE UMBILICAL CORD CLAMP CUTTER
K021055 · Busse Hospital Disposables, Inc. · Apr 2002
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
K012917 · Dynarex Corp. · Nov 2001
POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385
K010835 · Busse Hospital Disposables, Inc. · Apr 2001
UMBICUT
K000227 · Pollak (Intl.), Ltd. · Apr 2000
UMBILICAL CORD CLAMP
K994367 · Medical Sales Co. · Mar 2000