510(k) · Cleared

Recalled · 2010

Sterrad Sterilization Pouch

K951295510(k) TraditionalCleared May 19, 199558-day reviewClass II21 CFR 880.6850Recalls 1

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

Advanced Sterilization Products · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Cleared on May 19, 1995 after a 58-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 28 later devices descend from it. It has been recalled once.

Decided: May 19, 1995
Review: 58 days
Class: Class II
Product code: KCT
Recalls: 1
Predicates: 0

28 later devices descend from it, 2 citing it directly.

This deviceK951295 Sterrad Sterilization PouchAdvanced Sterilization Products · 1995
Descendant · cites it directly · 15 of its ownK103210 Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad…Advanced Sterilization Products · 2011
Descendant · cites it directly · 11 of its ownK071087 Vis-U-All II Heat-Seal Pouch and TubingSTERIS Corporation · 2007
Descendant · 2 generations on · 10 of its ownK133838 Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corp. · 2015
Descendant · 3 generations on · 9 of its ownK180672 Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation · 2018
Descendant · 2 generations on · 9 of its ownK090371 Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1…STERIS Corporation · 2009

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2007high 8 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 28 · See all

K103210Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with…Advanced Sterilization Products · 2011 · cites it directly15descendants
K071087Vis-U-All II Heat-Seal Pouch and TubingSTERIS Corporation · 2007 · cites it directly11descendants
K133838Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corp. · 2015 · 2 generations on10descendants
K180672Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation · 2018 · 3 generations on9descendants
K090371Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization SystemSTERIS Corporation · 2009 · 2 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K951295	Sterrad Sterilization Pouch	Advanced Sterilization Products	1995	—
+1	K103210	Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek…	Advanced Sterilization Products	2011	—
+1	K071087	Vis-U-All II Heat-Seal Pouch and Tubing	STERIS Corporation	2007	—
+2	K133838	Sterilization Pouch/Roll Made with Tyvek	Sigma Medical Supplies Corp.	2015	—
+3	K180672	Sterilization Pouch/Roll Made with Tyvek	Sigma Medical Supplies Corporation	2018	—
+2	K090371	Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization…	STERIS Corporation	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	1	0
2010	1	0
2011	1	0
2012	1	0
2014	3	0
2015	1	0
2016	2	0
2017	1	0
2018	2	0
2019	2	0
2021	1	0
2022	2	0
2023	8	0
2024	1	0

FIG. 1 — Lineage of K951295, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K103210	Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with…	Advanced Sterilization Products	2011	15
K071087	Vis-U-All II Heat-Seal Pouch and Tubing	STERIS Corporation	2007	11

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 23, 2010	Not classified	Z-1393-2011	Process control	The recall was initiated after Advanced Sterilization Products (ASP) discovered a non-conforming lot. The misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K103210 (Advanced Sterilization Products, 2011) has gone furthest, with 15 descendants of its own.

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	—

https://510kreport.com/device/K951295 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951295: Sterrad 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/K951295

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026