510(k) · Cleared

Cleared

Monoject Insulin Syringe

K991758510(k) AbbreviatedCleared Jun 14, 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

Cleared on Jun 14, 1999 as substantially equivalent to K851090 (Sherwood Medical Co., 1985) and 3 other predicates after a 21-day review. Its family tree reaches back 1 generation to 1985. 3 later devices descend from it.

Decided: Jun 14, 1999
Review: 21 days
Class: Class II
Product code: FMF
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K851090 (1985). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK851090 Monoject Sterile 1/2 CC & 1CC Syringes W & W/O NeeSherwood Medical Co. · 1985 · Recalled
This deviceK991758 Monoject Insulin SyringeThe Kendal Co. · 1999
Descendant · cites it directly · 0 of its ownK160589 Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc. · 2017
Descendant · cites it directly · 0 of its ownK081547 Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc. · 2008
Descendant · cites it directly · 0 of its ownK033373 Monoject Insulin SyringeTyco Healthcare · 2003 · Recalled

Most influential descendants

Showing 3 of 3 · See all

K160589Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc. · 2017 · cites it directly0descendants
K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc. · 2008 · cites it directly0descendants
K033373Monoject Insulin SyringeTyco Healthcare · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K851090	Monoject Sterile 1/2 CC & 1CC Syringes W & W/O Nee	Sherwood Medical Co.	1985	1
0 (this device)	K991758	Monoject Insulin Syringe	The Kendal Co.	1999	—
+1	K160589	Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe	Certa Dose, Inc.	2017	—
+1	K081547	Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CC	Bio-Med USA, Inc.	2008	—
+1	K033373	Monoject Insulin Syringe	Tyco Healthcare	2003	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1996	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2008	1	0
2017	1	0

FIG. 1 — Lineage of K991758, 1985–2017Source: 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? (4)

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
*	K851090	Monoject Sterile 1/2 CC & 1CC Syringes W & W/O Nee Summary page 1 …Insulin Syringe Predicate Devices: Monoject Insulin Syringes are substantially equivalent in intended use, function and composition to Monoject Insulin Syringe, 510K #s K851090 and K922522 and B-D Insulin Syringes, 510K #s K955235 and K980580. Device Description/Intended Use: Monoject Insulin Syringes ar…	Sherwood Medical Co.	1985	1
*	K922522	Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes Summary page 1 …nge Predicate Devices: Monoject Insulin Syringes are substantially equivalent in intended use, function and composition to Monoject Insulin Syringe, 510K #s K851090 and K922522 and B-D Insulin Syringes, 510K #s K955235 and K980580. Device Description/Intended Use: Monoject Insulin Syringes are used for s…	Sherwood Medical Co.	1992	4
*	K955235	B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe Summary page 1 …yringes are substantially equivalent in intended use, function and composition to Monoject Insulin Syringe, 510K #s K851090 and K922522 and B-D Insulin Syringes, 510K #s K955235 and K980580. Device Description/Intended Use: Monoject Insulin Syringes are used for subcutaneous injection of U-100 Insulin. Th…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	1
*	K980580	Becton Dickinson Syringes Summary page 1 …substantially equivalent in intended use, function and composition to Monoject Insulin Syringe, 510K #s K851090 and K922522 and B-D Insulin Syringes, 510K #s K955235 and K980580. Device Description/Intended Use: Monoject Insulin Syringes are used for subcutaneous injection of U-100 Insulin. These devices…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	—

Also cleared against K851090: 2 other devices →

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided
K160589	Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe	Certa Dose, Inc.	2017
K081547	Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CC	Bio-Med USA, Inc.	2008
K033373	Monoject Insulin Syringe	Tyco Healthcare	2003

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?

3 of the 4 ancestors have a recall of any class.
Of its descendants, K160589 (Certa Dose, Inc., 2017) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K851090.

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?

MONOIJECT Insulin Syringes are used for subcutaneous injection of U-100 Insulin.

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/K991758 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991758: Monoject Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991758

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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