510(k) · Cleared

Cleared

Disetronic Pen P100

K993666510(k) SpecialCleared Nov 22, 199921-day reviewClass II21 CFR 880.5860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Disetronic Medical Systems · FMF Syringe, Piston

Cleared on Nov 22, 1999 as substantially equivalent to K982966 (Disetronic Medical Systems, 1998) and 4 other predicates after a 21-day review. Its family tree reaches back 3 generations to 1991.

Decided: Nov 22, 1999
Review: 21 days
Class: Class II
Product code: FMF
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K905693 (1991). 10 ancestors in all, the oldest K895890 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK905693 H-Tron V 100 Insulin Infusion PumpDisetronic Medical Systems · 1991 · Recalled
2 generations backK973044 Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems · 1997 · Recalled
1 generation backK982966 Disetronic PenDisetronic Medical Systems · 1998
This deviceK993666 Disetronic Pen P100Disetronic Medical Systems · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K905693	H-Tron V 100 Insulin Infusion Pump	Disetronic Medical Systems	1991	1
−2	K973044	Disetronic H-Tron Plus V 100 Insulin Infusion Pump	Disetronic Medical Systems	1997	5
−1	K982966	Disetronic Pen	Disetronic Medical Systems	1998	—
0 (this device)	K993666	Disetronic Pen P100	Disetronic Medical Systems	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1995	2	0
1998	4	0

FIG. 1 — Lineage of K993666, 1991–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FMF device

#1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K982966	Disetronic Pen Summary page 1 ….3 Classification Name: Piston Syringe 9.4 Substantial Equivaltence: The Disetronic Pen-P100 is substantially equivatent tothe current Disetronic Insulin injection Pen (K982966), the B-D 3 ml Injection Pen (K980755), the B-D 3 ml Ultra Injection Pen (K981797), the Eli Lilly and Company HumaPen and HumaPen…	Disetronic Medical Systems	1998	—
*	K980755	B-D E ML Pen Summary page 1 …9.4 Substantial Equivaltence: The Disetronic Pen-P100 is substantially equivatent tothe current Disetronic Insulin injection Pen (K982966), the B-D 3 ml Injection Pen (K980755), the B-D 3 ml Ultra Injection Pen (K981797), the Eli Lilly and Company HumaPen and HumaPen Ergo (K982842) and the Owen Mumford A…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	—
*	K981797	B-D Pen Ultra Summary page 1 …ic Pen-P100 is substantially equivatent tothe current Disetronic Insulin injection Pen (K982966), the B-D 3 ml Injection Pen (K980755), the B-D 3 ml Ultra Injection Pen (K981797), the Eli Lilly and Company HumaPen and HumaPen Ergo (K982842) and the Owen Mumford Autopen 3mi (K983974). 9.5 The Disetronic Pe…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	—
*	K982842	Humapen and Humapen Ergo Summary page 1 …ic Insulin injection Pen (K982966), the B-D 3 ml Injection Pen (K980755), the B-D 3 ml Ultra Injection Pen (K981797), the Eli Lilly and Company HumaPen and HumaPen Ergo (K982842) and the Owen Mumford Autopen 3mi (K983974). 9.5 The Disetronic Pen P100 is a reusable device that provides a method of accurate…	Eli Lilly and Co.	1998	—
*	K983974	Owen Mumford 3ML Autopen Summary page 1 …3 ml Injection Pen (K980755), the B-D 3 ml Ultra Injection Pen (K981797), the Eli Lilly and Company HumaPen and HumaPen Ergo (K982842) and the Owen Mumford Autopen 3mi (K983974). 9.5 The Disetronic Pen P100 is a reusable device that provides a method of accurately injecting a selected dose of insulin fro…	Owen Mumford USA, Inc.	1998	1

Also cleared against K982966: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
3 of the 10 ancestors have a recall of any class.
2 other devices also cite its predicate K982966.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007high 239 (2026) · low 74 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMF

19in 2023

2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	23	90	6	674
2008	9	74	11	691
2009	14	94	15	913
2010	11	130	12	679
2011	16	109	3	186
2012	9	86	6	307
2013	12	154	1	326
2014	13	84	1	244
2015	11	87	2	273
2016	12	146	0	684
2017	13	135	3	1,858
2018	8	87	2	3,952
2019	11	146	1	5,863
2020	15	107	2	5,334
2021	20	175	1	5,874
2022	24	211	2	5,233
2023	22	173	19 (18)	5,214
2024	14	130	0	5,122
2025	13	114	0	4,181
2026	9	239	2 (1)	—

What is it indicated for?

The Disetronic Pen P100 is indicated for the injection of insulin inta the body

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993666 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993666: Disetronic Pen P100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993666

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026