510(k) · Cleared

Cleared

Surgical Instrument Tray

K944025510(k) TraditionalCleared Nov 22, 199497-day reviewClass I21 CFR 878.4800

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

Riley Medical, Inc. · FSM Tray, Surgical, Instrument

Cleared on Nov 22, 1994 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 153 devices in its family, counting itself, has a Class I recall. 152 later devices descend from it.

Decided: Nov 22, 1994
Review: 97 days
Class: Class I
Product code: FSM
Recalls: None
Predicates: 0

152 later devices descend from it, 4 citing it directly. 1 of the 153 devices in this family, counting this one, has a Class I recall.

This deviceK944025 Surgical Instrument TrayRiley Medical, Inc. · 1994
Descendant · cites it directly · 150 of its ownK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
Descendant · cites it directly · 149 of its ownK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
Descendant · cites it directly · 130 of its ownK993535 Metapak Multi-Purpose Instrument TrayRiley Medical, Inc. · 2001
Descendant · 2 generations on · 58 of its ownK033222 Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004
Descendant · 2 generations on · 46 of its ownK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004

Showing 5 of 152 descendants. See all descendants

Descendants cleared per year

1999high 19 (2021) · low 0 (2000)2026

Class I recalls in this family

K050220 Evis Exera Bronchovideoscope, Olympus…3 generations on · 2005

Most influential descendants

Showing 5 of 152 · See all

K990761Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999 · cites it directly150descendants
K012105Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002 · cites it directly149descendants
K993535Metapak Multi-Purpose Instrument TrayRiley Medical, Inc. · 2001 · cites it directly130descendants
K033222Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004 · 2 generations on58descendants
K040223Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004 · 2 generations on46descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K944025	Surgical Instrument Tray	Riley Medical, Inc.	1994	—
+1	K990761	Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette	Tuttnauer U.S.A Co, Ltd.	1999	—
+1	K012105	Polyvac Surgical Instrument Delivery System	Symmetry Medical, Inc.	2002	—
+1	K993535	Metapak Multi-Purpose Instrument Tray	Riley Medical, Inc.	2001	—
+2	K033222	Olympus Sterilization Trays	Olympus Winter & Ibe GmbH	2004	—
+2	K040223	Polyvac Instrument Delivery System	Symmetry Medical USA, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2002	1	0
2003	3	0
2004	2	0
2005	1	1
2006	1	0
2007	1	0
2008	4	0
2009	3	0
2010	7	0
2011	3	0
2012	3	0
2013	7	0
2014	4	0
2015	4	0
2016	5	0
2017	6	0
2018	11	0
2019	15	0
2020	10	0
2021	19	0
2022	9	0
2023	10	0
2024	7	0
2025	9	0
2026	5	0

FIG. 1 — Lineage of K944025, 1994–2026Source: 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.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

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? (152)

See all 152

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

Number	Device	Applicant	Decided	Descendants
K990761	Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette	Tuttnauer U.S.A Co, Ltd.	1999	150
K012105	Polyvac Surgical Instrument Delivery System	Symmetry Medical, Inc.	2002	149
K993535	Metapak Multi-Purpose Instrument Tray	Riley Medical, Inc.	2001	130
K052992	Conmed Linvatec Instrument Sterilization Tray	Conmed Linvatec	2006	42

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation · 2005 · 3 generations on · ◆ in the 2005 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Of its descendants, K990761 (Tuttnauer U.S.A Co, Ltd., 1999) has gone furthest, with 150 descendants of its own.

How does its category compare?

All FSM devices

FSM Tray, Surgical, Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FSM

FDA has decided no FSM device since 2007.

Median 510(k) review, days · FSM

Too few FSM 510(k)s in any year since 2007 to give a median.

Recalls per year · FSM

2in 2022

2007high 9 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FSM

274in 2025

2007high 288 (2024) · low 0 (2009)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	2
2008	—	0	1
2009	—	0	0
2010	—	0	2
2011	—	1	8
2012	—	9	10
2013	—	0	81
2014	—	0	46
2015	—	2	79
2016	—	2	90
2017	—	0	132
2018	—	2	104
2019	—	0	168
2020	—	0	148
2021	—	1	153
2022	—	2	200
2023	—	0	168
2024	—	0	288
2025	—	0	274
2026	—	4	—

https://510kreport.com/device/K944025 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944025: Surgical Instrument Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944025

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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