Cleared Special

K170622 - Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K170622 · Cook Incorporated · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Mar 2017
Decision
30d
Days
Class 2
Risk

K170622 is an FDA 510(k) clearance for the Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Co.... Classified as Intrauterine Tamponade Balloon (product code OQY), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on March 31, 2017 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cook Incorporated devices

Submission Details

510(k) Number K170622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2017
Decision Date March 31, 2017
Days to Decision 30 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 160d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.