Data / Medical devices / United States / The Jay Group

The Jay Group: FDA-registered device maker in Lancaster, PA, United States, 13 510(k) clearances

Name: The Jay Group FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The Jay Group is registered with the FDA (registration 3006479639) in Lancaster, PA, United States. It lists 14 device types. The FDA files 13 510(k) clearances under its listings, the newest dated March 7, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006479639
Address: 700 Indian Springs Drive, Lancaster, PA, United States, 17601
Owner or operator: The Jay Group (10021837)
Roles: Repackager or relabeler
First device listed: October 2, 2007
Registered through: 2026
Brand names listed: Animas, BD, Banana Gold, Fillow, HEX Condoms Original 12 Pack (US_TNR); HEX Condoms Original 3 Pack (US_TNR); HEX Condoms Original 36 Pack (US_TNR); HEX, HEX Condoms Respect 12 Pack; HEX Condoms Respect 3 Pack; HEX Condoms Respect 36 Pack; LELO RESPECT HEX Natural Rubber La, Healthyio, Lelo Hex Lubricated Natural Rubber Latex Condom; Lelo Hex Lubricated Natural Rubber Latex Condom 12s; Lelo Hex Lubricat and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Urinalysis System	KQO	1	Repackager or relabeler	accessdata.fda.gov
Condom	HIS	2	Repackager or relabeler	accessdata.fda.gov
Cup, Menstrual	HHE	2	Repackager or relabeler	accessdata.fda.gov
Device, External Penile Rigidity	LKY	2	Repackager or relabeler	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Repackager or relabeler	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Repackager or relabeler	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Repackager or relabeler	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Repackager or relabeler	accessdata.fda.gov
Pad, Menstrual, Unscented	HHD	1	Repackager or relabeler	accessdata.fda.gov
Perineometer	HIR	2	Repackager or relabeler	accessdata.fda.gov
Pump, Infusion, Insulin	LZG	2	Repackager or relabeler	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Repackager or relabeler	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Repackager or relabeler	accessdata.fda.gov
Tampon, Menstrual, Unscented	HEB	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 7, 2025	K243421	Lelo Hex Lubricated Natural Rubber Latex Condom	HIS	Substantially Equivalent	Lelo, Inc.	accessdata.fda.gov
August 3, 2023	K230419	Sequel Tampon with Plastic Applicator	HEB	Substantially Equivalent	Tampro, Inc.	accessdata.fda.gov
July 6, 2022	K210069	Minuteful - kidney test	JIR	Substantially Equivalent	Healthy.Io, Ltd.	accessdata.fda.gov
January 13, 2017	K162511	LELO RESPECT HEX Natural Rubber Latex Condom	HIS	Substantially Equivalent	Lelo, Inc.	accessdata.fda.gov
June 30, 2016	K160644	Lelo Hex Natural Rubber Latex Condom	HIS	Substantially Equivalent	Lelo, Inc.	accessdata.fda.gov
August 14, 2015	K150857	Banana Gold	HIS	Substantially Equivalent	Hankook Latex Gongup Co., Ltd.	accessdata.fda.gov
September 10, 2014	K140780	KEGEL SMART, KEGELSMART PEARL	HIR	Substantially Equivalent	Regulatory Insight, Inc.	accessdata.fda.gov
June 30, 2004	K041545	CONTACT DETACH	FPA	Substantially Equivalent	Unomedical A/S	accessdata.fda.gov
October 16, 2003	K032257	MODEL IR 1200 INSULIN PUMP	LZG	Substantially Equivalent	Animas Corp.	accessdata.fda.gov
October 9, 2003	K032854	UNOMEDICAL MONICA INFUSION SET	FPA	Substantially Equivalent	Unomedical A/S	accessdata.fda.gov
May 29, 2002	K021439	MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO	LZG	Substantially Equivalent	Animas Corp.	accessdata.fda.gov
December 19, 1997	K973825	MIDSTREAM HOME REGNANCY TEST	DHA	Substantially Equivalent	Germaine Laboratories, Inc.	accessdata.fda.gov
August 26, 1997	K972135	MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET	FPA	Substantially Equivalent	P/L Biomedical	accessdata.fda.gov

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Updated March 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.