510(k) · Cleared

Cleared

TSO3 Ozone Sterilization Wrap

K080198510(k) TraditionalCleared May 30, 2008126-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

Tso3, Inc. · FRG Wrap, Sterilization

Cleared on May 30, 2008 as substantially equivalent to K990300 (Allegiance Healthcare Corp., 1999) after a 126-day review. Its family tree reaches back 2 generations to 1992.

Decided: May 30, 2008
Review: 126 days
Class: Class II
Product code: FRG
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K921243 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK921243 Convertors Sterilization WrapBaxter Healthcare Corp · 1992
1 generation backK990300 Suprashield Express Sterilization WrapAllegiance Healthcare Corp. · 1999
This deviceK080198 TSO3 Ozone Sterilization WrapTso3, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K921243	Convertors Sterilization Wrap	Baxter Healthcare Corp	1992	—
−1	K990300	Suprashield Express Sterilization Wrap	Allegiance Healthcare Corp.	1999	—
0 (this device)	K080198	TSO3 Ozone Sterilization Wrap	Tso3, Inc.	2008	—

FIG. 1 — Lineage of K080198, 1992–2008Source: 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
*	K990300	Suprashield Express Sterilization Wrap Summary page 1 …Name Wrap, Sterilization Class II (as per 21 CFR, part 880.6850 equivalent device) Legally Marketed Equivalent Device Name(s) Suprashield Express®V Sterilization Wrap (K9903 00) Page ii I TSO() Description of…	Allegiance Healthcare Corp.	1999	—
†	K020875	TSO3 Ozone Sterilizer, Model 125L	Technologies of Sterilization With Oxone, Tso3, Inc.	2003	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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?

The TS0 3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is

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 wrap

is intended for use with TSO 3 Ozone Sterilization process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080198 · printed Nov 4, 2026

Cite this page

510(k) Report. “K080198: TSO3 Ozone Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080198

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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