Rinovum Subsidiary 2, LLC

Export, PA, US

RINOVUM SUBSIDIARY 2, LLC appears in FDA device records in Export, PA. FDA records list 2 510(k) clearances between 2014-07-11 and 2019-01-25, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Rinovum Subsidiary 2, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Rinovum Women'S Health, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Rinovum Subsidiary 2, LLC between 2014 and 2019. The busiest year on record is 2014, with 1. The most recent is 2019, with 1.

Clearances by year, as a table

510(k) clearance decisions for Rinovum Subsidiary 2, LLC, by decision year
Year	Clearances
2014	1
2019	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K183468	Revive Reusable Bladder Support	HHW	Substantially Equivalent	2019-01-25
K140186	THE STORK OTC	OBB	Substantially Equivalent	2014-07-11

Registered establishments

FDA registered establishments for Rinovum Subsidiary 2, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3015417614	3015417614	RINOVUM SUBSIDIARY 2, LLC	4923 Simmons Circle, Export, PA 15632 US	2026	HHW

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1952-2019	Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. The device comes in a sealed box, and contains a reusable bladder support and applicator, and disposable strings and travel case. The device is nonperishable and does not have an expiration date.	The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the product (31 uses).	Class II	2019-05-02	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain