510(k) · Cleared

Cleared

Allegiance Genesis Container System

K983299510(k) TraditionalCleared Aug 4, 2000683-day reviewClass II21 CFR 880.6850

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

Allegiance Healthcare Corp. · FRG Wrap, Sterilization

Cleared on Aug 4, 2000 as substantially equivalent to K844652 (General Medical Co., 1984) after a 683-day review. Its family tree reaches back 1 generation to 1984. 8 later devices descend from it.

Decided: Aug 4, 2000
Review: 683 days
Class: Class II
Product code: FRG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K844652 (1984). 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK844652 C.a.S.E. ContainerGeneral Medical Co. · 1984
This deviceK983299 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
Descendant · 3 generations on · 0 of its ownK181933 DePuy Synthes Sterilization Container SystemSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2012high 2 (2014) · low 0 (2013)2026

Most influential descendants

Showing 5 of 8 · See all

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
K181933DePuy Synthes Sterilization Container SystemSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K844652	C.a.S.E. Container	General Medical Co.	1984	—
0 (this device)	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	—
+3	K181933	DePuy Synthes Sterilization Container System	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2019	—

Descendants by year cleared

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

FIG. 1 — Lineage of K983299, 1984–2019Source: 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 FRG? 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 FRG device

#1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 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? (3)

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
*	K844652	C.a.S.E. Container Summary page 1 …September 2, 1998 Product Trade Name: Alleglance Genesis™ Container System Common Name: Sterilization Contalner Classification: Sterilization Wrap Pradicate Device: (K844652) C.A.S.E.™ Contalner System Descriptian: ' The Allegiance Genesis™ Container System \|s a reusable device which featuras an asso…	General Medical Co.	1984	—
*	—	Dental, Medical Instrument Cases & Cassettes by Sterilization Cassette Systems, Inc. Named without a submission number			—
*	—	Aesculap Sterilization Container Named without a submission number			—

Also cleared against K844652: 1 other device →

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
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?

Its one ancestor has no recall.
Of its descendants, K112535 (Carefusion 2200, Inc., 2012) has gone furthest, with 7 descendants of its own.
1 other device also cites its predicate K844652.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRG

9in 2025

2007high 12 (2015) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRG

151in 2025

2007high 260 (2017) · low 110 (2011)2026

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

Recalls per year · FRG

2in 2022

2007high 29 (2017) · low 0 (2007)2026

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

Adverse event reports per year · FRG

18in 2025

2007high 22 (2018) · low 0 (2010)2025

MAUDE reports naming product code FRG, 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	3	182	0	1
2008	2	—	0	2
2009	4	171	0	2
2010	4	213	0	0
2011	6	110	0	12
2012	10	133	0	4
2013	6	146	2	5
2014	8	177	0	13
2015	12	196	0	9
2016	9	131	0	20
2017	9	260	29	7
2018	5	150	0	22
2019	9	258	0	10
2020	5	122	14	21
2021	4	170	0	9
2022	9	217	2	4
2023	9	230	0	13
2024	11	182	0	21
2025	9	151	0	18
2026	4	247	0	—

What is it indicated for?

A sterilization container system, is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

This container system is intended to be used in prevacuum steam and ethylene oxide sterilization processes.

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/K983299 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983299: Allegiance Genesis Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983299

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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