Eli Lilly and Company, Pharmaceutical Delivery Systems

Indianapolis, IN, US

Eli Lilly and Company, Pharmaceutical Delivery Systems appears in FDA device records in Indianapolis, IN. FDA records list 9 510(k) clearances between 1998-09-25 and 2022-09-16, 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: 9
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Eli Lilly and Company, Pharmaceutical Delivery Systems 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.

Eli Lilly and Company, Inc.510(k), recall

510(k) clearance history

FDA records hold 9 510(k) clearances for Eli Lilly and Company, Pharmaceutical Delivery Systems between 1998 and 2022. The busiest year on record is 2015, with 2. The most recent is 2022, with 1.

Clearances by year, as a table

510(k) clearance decisions for Eli Lilly and Company, Pharmaceutical Delivery Systems, by decision year
Year	Clearances
1998	1
2006	1
2007	1
2010	1
2015	2
2016	2
2022	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K212217	Tempo Smart Button	QOG	Substantially Equivalent	2022-09-16
K160949	Go Dose System	NDC	Substantially Equivalent	2016-12-22
K160668	HumaPen Savvio	FMF	Substantially Equivalent	2016-06-03
K151686	HumanPen Ergo II	FMF	Substantially Equivalent	2015-12-30
K142518	HumaPen Luxura	FMF	Substantially Equivalent	2015-06-05
K100988	HUMAPEN LUXURA HD	FMF	Substantially Equivalent	2010-08-17
K063151	HUMAPEN LUXURA HD	NSC	Substantially Equivalent	2007-01-09
K053563	HUMAPEN MEMOIR	FMF	Substantially Equivalent	2006-04-07
K982842	HUMAPEN AND HUMAPEN ERGO	FMF	Substantially Equivalent	1998-09-25

Registered establishments

FDA registered establishments for Eli Lilly and Company, Pharmaceutical Delivery Systems, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1819470	1819470	Eli Lilly and Company, Pharmaceutical Delivery Systems	Lilly Corporate Center, Indianapolis, IN 46285 US	2026	FMF OCN QOG

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-2191-2011	Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guides, and freezer gel packs. Note: the kits do not contain the drug, Forteo. Intended use: Travel starter kits to hold the drug Forteo and supplies needed to deliver the subcutaneous injection.	Eli Lilly and Company announced 3/17/2011 that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kits for Forteo [teriparatide (rDNA origin) injection] in the United States.The Tri-ad Group is recalling the alcohol prep pads due to potential contamination with the bacteria, Ba-cillus cereus, which could result in life threatening infecti		2011-03-17	Terminated

Verification record

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