Cleared Traditional

K101535 - BT-CATH

K101535 is an FDA 510(k) clearance for BT-CATH, manufactured by Utah Medical Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code OQY cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K101535 · Utah Medical Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
222d
Days
Class 2
Risk

K101535 is an FDA 510(k) clearance for the BT-CATH. Classified as Intrauterine Tamponade Balloon (product code OQY), Class II - Special Controls.

Submitted by Utah Medical Products, Inc. (Midvale, US). The FDA issued a Cleared decision on January 11, 2011 after a review of 222 days - an extended review 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: 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 Utah Medical Products, Inc. devices

FDA 510(k) Submission Details - K101535

510(k) Number K101535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2010
Decision Date January 11, 2011
Days to Decision 222 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
61d slower than avg
Panel avg: 161d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OQY Device Classification - Class 2, Special Controls

Product Code OQY Intrauterine Tamponade Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
Definition Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding
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 - OQY Intrauterine Tamponade Balloon

All 10
Devices cleared under the same product code (OQY) and FDA review panel - the closest regulatory comparables to K101535.
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
K170622 · Cook Incorporated · Mar 2017
ebb Complete Tamponade System
K153591 · Clinical Innovations, LLC · Jan 2016
ebb Complete Tamponade System
K150573 · Clinical Innovations, LLC · Mar 2015
BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM
K091958 · Glenveigh Surgical, LLC · Apr 2010