510(k) · Cleared

Cleared

Genesis Sterrad Compatible Reusable Sterilization Container System

K012931510(k) TraditionalCleared Aug 20, 2002354-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 20, 2002 as substantially equivalent to K991023 (Case Medical, Inc., 2000) after a 354-day review. Its family tree reaches back 1 generation to 2000. 18 later devices descend from it.

Decided: Aug 20, 2002
Review: 354 days
Class: Class II
Product code: FRG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K991023 (2000). 18 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK991023 Steritite Perforated Bottom Rigid Reusable Sterilization Container…Case Medical, Inc. · 2000
This deviceK012931 Genesis Sterrad Compatible Reusable Sterilization Container SystemAllegiance Healthcare Corp. · 2002
Descendant · cites it directly · 9 of its ownK023614 Steritite Rigid Reusable Sterilization Container SystemCase Medical, Inc. · 2003 · Recalled
Descendant · cites it directly · 7 of its ownK112535 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2012
Descendant · 2 generations on · 7 of its ownK050570 Miltex Rigid Sterilization Container SystemMiltex, Inc. · 2005
Descendant · 3 generations on · 6 of its ownK091720 Sklarlite Rigid Sterilization Container SystemSklar Corp. · 2010
Descendant · 2 generations on · 3 of its ownK140850 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2014

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2003high 3 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 18 · See all

K023614Steritite Rigid Reusable Sterilization Container SystemCase Medical, Inc. · 2003 · cites it directly9descendants
K112535Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2012 · cites it directly7descendants
K050570Miltex Rigid Sterilization Container SystemMiltex, Inc. · 2005 · 2 generations on7descendants
K091720Sklarlite Rigid Sterilization Container SystemSklar Corp. · 2010 · 3 generations on6descendants
K140850Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2014 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991023	Steritite Perforated Bottom Rigid Reusable Sterilization Container System with…	Case Medical, Inc.	2000	—
0 (this device)	K012931	Genesis Sterrad Compatible Reusable Sterilization Container System	Allegiance Healthcare Corp.	2002	—
+1	K023614	Steritite Rigid Reusable Sterilization Container System	Case Medical, Inc.	2003	1
+1	K112535	Genesis Reusable Rigid Container System	Carefusion 2200, Inc.	2012	—
+2	K050570	Miltex Rigid Sterilization Container System	Miltex, Inc.	2005	—
+3	K091720	Sklarlite Rigid Sterilization Container System	Sklar Corp.	2010	—
+2	K140850	Genesis Reusable Rigid Container System	Carefusion 2200, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2006	1	0
2010	2	0
2012	2	0
2013	1	0
2014	3	0
2015	2	0
2016	2	0
2018	1	0
2019	1	0
2024	1	0

FIG. 1 — Lineage of K012931, 2000–2024Source: 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

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What was it cleared against? (1)

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
*	K991023	Steritite Perforated Bottom Rigid Reusable Sterilization Container System with SCF02 -… Summary page 1 …Common Name: Sterilization Container Classification: Sterilization Wrap Predicate Device: (K991023) SteriTite perforated base rigid reusable sterilization…	Case Medical, Inc.	2000	—

Also cleared against K991023: 2 other devices →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K023614	Steritite Rigid Reusable Sterilization Container System	Case Medical, Inc.	2003	9
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, K023614 (Case Medical, Inc., 2003) has gone furthest, with 9 descendants of its own.
2 other devices also cite its predicate K991023.

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 STERRADB 50, STERRAD@ 100 and STERRADB IOOS, ethylene oxide and pre-vacuum sterilization processes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K012931 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012931: Genesis Sterrad Compatible Reusable Sterilization Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012931

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026