510(k) · Cleared

Cleared

Safepass Sterilization Pouch

K973981510(k) TraditionalCleared Jan 29, 1998101-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

Adroit Medical Systems, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Cleared on Jan 29, 1998 as substantially equivalent to K921243 (Baxter Healthcare Corp, 1992) after a 101-day review. Its family tree reaches back 1 generation to 1992.

Decided: Jan 29, 1998
Review: 101 days
Class: Class II
Product code: KCT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K921243 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK921243 Convertors Sterilization WrapBaxter Healthcare Corp · 1992
This deviceK973981 Safepass Sterilization PouchAdroit Medical Systems, Inc. · 1998

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)	K973981	Safepass Sterilization Pouch	Adroit Medical Systems, Inc.	1998	—

FIG. 1 — Lineage of K973981, 1992–1998Source: 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 KCT? 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 KCT device

#1 K214041 Aesculap AICON Containerscore 18.1 · 6 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
*	K921243	Convertors Sterilization Wrap Summary page 1 …al Systems, Inc. believes that SafePASS Sterilization Pouches are substantially equivalent to the various sizes of SupraShield hospital sterilization wrap, 510(k) number K921243, marketed by V. Mueller, a division of Allegiance Healthcare Corporation (formerly a division of Baxter International Corporation…	Baxter Healthcare Corp	1992	—

Also cleared against K921243: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K921243.

How does its category compare?

All KCT devices

KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KCT

11in 2025

2007high 18 (2019) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KCT

205in 2025

2007high 236 (2012) · low 89 (2009)2026

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

Recalls per year · KCT

17in 2022

2007high 17 (2022) · low 0 (2007)2026

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

Adverse event reports per year · KCT

50in 2025

2007high 66 (2020) · low 2 (2007)2025

MAUDE reports naming product code KCT, 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	199	0	2
2008	6	182	0	8
2009	6	89	0	5
2010	12	202	1	3
2011	6	117	2	3
2012	10	236	0	2
2013	8	131	1	6
2014	11	169	1	5
2015	15	151	0	6
2016	12	182	3	16
2017	10	211	1	3
2018	15	192	0	22
2019	18	187	0	15
2020	14	134	0	66
2021	18	185	1	26
2022	11	137	17	8
2023	10	94	0	30
2024	8	106	0	18
2025	11	205	0	50
2026	9	122	0	—

What is it indicated for?

SafePASS Sterilization Pouches are intended for use as sterility barrier packaging in the steam sterilization of various medical devices, kits, instruments, etc.

A SafePASS Sterilization Pouch is intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

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/K973981 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973981: Safepass Sterilization Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973981

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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