510(k) · Cleared

Cleared

C.a.S.E. Container

K844652510(k) TraditionalCleared Dec 12, 198413-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

General Medical Co. · FSM Tray, Surgical, Instrument

Cleared on Dec 12, 1984 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided: Dec 12, 1984
Review: 13 days
Class: Class I
Product code: FSM
Recalls: None
Predicates: 0

9 later devices descend from it, 2 citing it directly.

This deviceK844652 C.a.S.E. ContainerGeneral Medical Co. · 1984
Descendant · cites it directly · 8 of its ownK983299 Allegiance Genesis Container SystemAllegiance Healthcare Corp. · 2000
Descendant · cites it directly · 7 of its ownK112535 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2012
Descendant · 2 generations on · 3 of its ownK140850 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2014
Descendant · 3 generations on · 2 of its ownK142529 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2015 · Recalled
Descendant · 2 generations on · 1 of its ownK130720 Synthes Reusable Sterilization Container SystemSynthes (USA) Products, LLC · 2014

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2000high 2 (2014) · low 0 (2001)2026

Most influential descendants

Showing 5 of 9 · See all

K983299Allegiance Genesis Container SystemAllegiance Healthcare Corp. · 2000 · cites it directly8descendants
K112535Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2012 · cites it directly7descendants
K140850Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2014 · 2 generations on3descendants
K142529Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2015 · 3 generations on2descendants
K130720Synthes Reusable Sterilization Container SystemSynthes (USA) Products, LLC · 2014 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K844652	C.a.S.E. Container	General Medical Co.	1984	—
+1	K983299	Allegiance Genesis Container System	Allegiance Healthcare Corp.	2000	—
+1	K112535	Genesis Reusable Rigid Container System	Carefusion 2200, Inc.	2012	—
+2	K140850	Genesis Reusable Rigid Container System	Carefusion 2200, Inc.	2014	—
+3	K142529	Genesis Reusable Rigid Container System	Carefusion 2200, Inc.	2015	2
+2	K130720	Synthes Reusable Sterilization Container System	Synthes (USA) Products, LLC	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2012	1	0
2014	2	0
2015	2	0
2016	2	0
2019	1	0

FIG. 1 — Lineage of K844652, 1984–2019Source: 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 FSM? 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? (9)

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

Number	Device	Applicant	Decided	Descendants
K983299	Allegiance Genesis Container System	Allegiance Healthcare Corp.	2000	8
K112535	Genesis Reusable Rigid Container System	Carefusion 2200, Inc.	2012	7

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?

Of its descendants, K983299 (Allegiance Healthcare Corp., 2000) has gone furthest, with 8 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/K844652 · printed Nov 6, 2026

Cite this page

510(k) Report. “K844652: C.a.S.E. Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K844652

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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