Cleared Traditional

K012917 - DYNAREX UMBILICAL CORD LAMP

K012917 is an FDA 510(k) clearance for DYNAREX UMBILICAL CORD LAMP, manufactured by Dynarex Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K012917 · Dynarex Corp. · Obstetrics & Gynecology device
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Nov 2001
Decision
90d
Days
Class 2
Risk

K012917 is an FDA 510(k) clearance for the DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by Dynarex Corp. (Maineville, US). The FDA issued a Cleared decision on November 28, 2001 after a review of 90 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 Dynarex Corp. devices

FDA 510(k) Submission Details - K012917

510(k) Number K012917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2001
Decision Date November 28, 2001
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
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 12
Devices cleared under the same product code (HFW) and FDA review panel - the closest regulatory comparables to K012917.
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
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
SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
K994263 · Precision Dynamics Corp. · Jan 2000
'ECURLINE UMBILICAL CORD CLAMP #3500
K990737 · Precision Dynamics Corp. · Apr 1999