Cleared Traditional

K990737 - 'ECURLINE UMBILICAL CORD CLAMP #3500

K990737 is an FDA 510(k) clearance for 'ECURLINE UMBILICAL CORD CLAMP #3500, manufactured by Precision Dynamics Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K990737 · Precision Dynamics Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
32d
Days
Class 2
Risk

K990737 is an FDA 510(k) clearance for the 'ECURLINE UMBILICAL CORD CLAMP #3500. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by Precision Dynamics Corp. (San Fernando, US). The FDA issued a Cleared decision on April 6, 1999 after a review of 32 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 Precision Dynamics Corp. devices

FDA 510(k) Submission Details - K990737

510(k) Number K990737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1999
Decision Date April 06, 1999
Days to Decision 32 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
128d faster than avg
Panel avg: 160d · This submission: 32d
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 K990737.
UMBICUT
K000227 · Pollak (Intl.), Ltd. · Apr 2000
UMBILICAL CORD CLAMP
K994367 · Medical Sales Co. · Mar 2000
SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
K994263 · Precision Dynamics Corp. · Jan 2000
HARWILL MEDICAL U-KLIP UMBILICAL CLAMP
K983204 · Harwill Medical (Pty) , Ltd. · Feb 1999
HOSPITAL'S CLAMP
K974227 · Gps · Dec 1997
EZ-CIRC
K963223 · Phyllis Adams, Rn, Npc, Msn · Apr 1997