510(k) · Cleared

Recalled · Class II · 2020

Monoject Sterile M200 Aluminum/M250 Polypropylene

K854547510(k) TraditionalCleared Feb 4, 198683-day reviewClass II21 CFR 880.5570Recalls 18

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

Sherwood Medical Co. · FMI Needle, Hypodermic, Single Lumen

Cleared on Feb 4, 1986 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 18 times.

Decided: Feb 4, 1986
Review: 83 days
Class: Class II
Product code: FMI
Recalls: 18
Predicates: 0

5 later devices descend from it, 3 citing it directly.

This deviceK854547 Monoject Sterile M200 Aluminum/M250 PolypropyleneSherwood Medical Co. · 1986
Descendant · cites it directly · 2 of its ownK964654 Becton Dickinson Blunt Plastic CannulaBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
Descendant · 2 generations on · 1 of its ownK974363 Becton Dickinson Blunt Plastic CannulaBd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
Descendant · cites it directly · 0 of its ownK101309 Exelint Aluminum Hub Blunt NeedlesExelint International, Co. · 2010
Descendant · cites it directly · 0 of its ownK073122 Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic NeedleCovidien Lp, Formerly Registered AS Tyco Healthcar · 2007
Descendant · 3 generations on · 0 of its ownK013949 Universal Vial Access Spike with Needleless ConnectorChurchill Medical Systems, Inc. · 2002

Most influential descendants

Showing 5 of 5 · See all

K964654Becton Dickinson Blunt Plastic CannulaBd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · cites it directly2descendants
K974363Becton Dickinson Blunt Plastic CannulaBd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · 2 generations on1descendant
K101309Exelint Aluminum Hub Blunt NeedlesExelint International, Co. · 2010 · cites it directly0descendants
K073122Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic NeedleCovidien Lp, Formerly Registered AS Tyco Healthcar · 2007 · cites it directly0descendants
K013949Universal Vial Access Spike with Needleless ConnectorChurchill Medical Systems, Inc. · 2002 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K854547	Monoject Sterile M200 Aluminum/M250 Polypropylene	Sherwood Medical Co.	1986	—
+1	K964654	Becton Dickinson Blunt Plastic Cannula	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997	—
+2	K974363	Becton Dickinson Blunt Plastic Cannula	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	2
+1	K101309	Exelint Aluminum Hub Blunt Needles	Exelint International, Co.	2010	—
+1	K073122	Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic Needle	Covidien Lp, Formerly Registered AS Tyco Healthcar	2007	—
+3	K013949	Universal Vial Access Spike with Needleless Connector	Churchill Medical Systems, Inc.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
2002	1	0
2007	1	0
2010	1	0

FIG. 1 — Lineage of K854547, 1986–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in FMI? 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 FMI device

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K964654	Becton Dickinson Blunt Plastic Cannula	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997	2
K101309	Exelint Aluminum Hub Blunt Needles	Exelint International, Co.	2010	0
K073122	Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic Needle	Covidien Lp, Formerly Registered AS Tyco Healthcar	2007	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 25, 2020	Class II	Z-0424-2021	Under Investigation by firm	Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the…
Apr 30, 2019	Class II	Z-2043-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2044-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2049-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2048-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2042-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2038-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2047-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2036-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2052-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2040-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2051-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2037-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2041-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2046-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2050-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2039-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Apr 30, 2019	Class II	Z-2045-2019	Under Investigation by firm	Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

The 5 latest of 18 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K964654 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1997) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007high 263 (2020) · low 71 (2007)2026

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

Recalls per year · FMI

1in 2024

2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, 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	15	71	2	208
2008	10	85	4	177
2009	7	177	3	263
2010	15	119	79	249
2011	12	113	5	240
2012	17	107	1	215
2013	11	87	1	255
2014	14	155	3	287
2015	10	89	1	567
2016	20	217	0	941
2017	9	253	16	1,547
2018	20	176	0	2,398
2019	12	186	5	4,896
2020	11	263	3	4,245
2021	18	143	7	4,532
2022	23	189	0	4,885
2023	18	112	2	4,986
2024	3	90	1	4,053
2025	11	141	0	2,424
2026	12	119	1 (1)	—

https://510kreport.com/device/K854547 · printed Nov 6, 2026

Cite this page

510(k) Report. “K854547: Monoject Sterile M200 Aluminum/M250 Polypropylene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854547

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026