Cleared Traditional

K033846 - KAEN YIH UMBILICAL CORD CLAMP

K033846 is an FDA 510(k) clearance for KAEN YIH UMBILICAL CORD CLAMP, manufactured by Kaen Yih Enterprise Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K033846 · Kaen Yih Enterprise Co., Ltd. · Obstetrics & Gynecology device
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Mar 2004
Decision
91d
Days
Class 2
Risk

K033846 is an FDA 510(k) clearance for the KAEN YIH UMBILICAL CORD CLAMP. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by Kaen Yih Enterprise Co., Ltd. (Mc Henry, US). The FDA issued a Cleared decision on March 11, 2004 after a review of 91 days - within the typical 510(k) review window.

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.

View all Kaen Yih Enterprise Co., Ltd. devices

FDA 510(k) Submission Details - K033846

510(k) Number K033846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2003
Decision Date March 11, 2004
Days to Decision 91 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 160d · This submission: 91d
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 K033846.
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