Cleared Traditional

K912419 - CORDGUARD BLOOD COLLECTION DEVICE

K912419 is an FDA 510(k) clearance for CORDGUARD BLOOD COLLECTION DEVICE, manufactured by O.B. Tech., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 493-day FDA review.

K912419 · O.B. Tech., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
493d
Days
Class 2
Risk

K912419 is an FDA 510(k) clearance for the CORDGUARD BLOOD COLLECTION DEVICE. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by O.B. Tech., Inc. (Huntington Beach, US). The FDA issued a Cleared decision on October 5, 1992 after a review of 493 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all O.B. Tech., Inc. devices

FDA 510(k) Submission Details - K912419

510(k) Number K912419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1991
Decision Date October 05, 1992
Days to Decision 493 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
333d slower than avg
Panel avg: 160d · This submission: 493d
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 20
Devices cleared under the same product code (HFW) and FDA review panel - the closest regulatory comparables to K912419.
QFC UMBILICAL CLAMP
K963889 · Qfc Industries · Apr 1997
UMBILICAL CLAMP AND CUTTER
K963428 · R.O.S.T. Medical Development, Inc. · Apr 1997
AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER
K934525 · United States Surgical, A Division of Tyco Healthc · Feb 1994
LABOR DELIVERY TRAY
K912054 · Medical Device Inspection Co., Inc. · Jan 1992
AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC
K901954 · Hollister, Inc. · Jul 1990
COMPRESSION FORCEPS
K890382 · Kinetic Medical Products · Feb 1989