510(k) · Cleared

Cleared

Suprashield Express Sterilization Wrap

K990300510(k) SpecialCleared Feb 10, 19999-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 Feb 10, 1999 as substantially equivalent to K921243 (Baxter Healthcare Corp, 1992) after a 9-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.

Decided: Feb 10, 1999
Review: 9 days
Class: Class II
Product code: FRG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K921243 (1992). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK921243 Convertors Sterilization WrapBaxter Healthcare Corp · 1992
This deviceK990300 Suprashield Express Sterilization WrapAllegiance Healthcare Corp. · 1999
Descendant · cites it directly · 0 of its ownK080198 TSO3 Ozone Sterilization WrapTso3, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all

K080198TSO3 Ozone Sterilization WrapTso3, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K990300, 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

Get a 510(k) Report

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
*	K921243	Convertors Sterilization Wrap Summary page 1 …X: 847.785.2461 SUMMARY Manufacturer: Regulatory Affairs Contact Telephone: Date Summary Prepared. Product Trade Name: Common Name: Classification: Predicate Device: (K921243) Description: Intended Use: ATTACHMENTE OF SAFETY AND EFFECTIVENESS Allegiance Healthcare Corporation V. Mueller Business Un…	Baxter Healthcare Corp	1992	—

Also cleared against K921243: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K080198	TSO3 Ozone Sterilization Wrap	Tso3, Inc.	2008	0

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, K080198 (Tso3, Inc., 2008) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K921243.

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?

The SupraShield® Express™ Sterilization Wrap 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 wrap is intended for use in steam or ethylene oxide (EO) 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/K990300 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990300: Suprashield Express 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/K990300

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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