510(k) · Cleared

Cleared

Vis-U-All II Self Seal Pouch

K070765510(k) TraditionalCleared Oct 12, 2007206-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

STERIS Corporation · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Cleared on Oct 12, 2007 as substantially equivalent to K771032 (Surgicot, Inc., 1977) and 1 other predicate after a 206-day review. Its family tree reaches back 1 generation to 1977. 12 later devices descend from it.

Decided: Oct 12, 2007
Review: 206 days
Class: Class II
Product code: KCT
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K771032 (1977). 2 ancestors in all. 12 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK771032 Pouches, Peel Open, BreathableSurgicot, Inc. · 1977
This deviceK070765 Vis-U-All II Self Seal PouchSTERIS Corporation · 2007
Descendant · cites it directly · 9 of its ownK090371 Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1…STERIS Corporation · 2009
Descendant · 2 generations on · 8 of its ownK140487 Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2014
Descendant · 3 generations on · 6 of its ownK160908 Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2016
Descendant · 4 generations on · 5 of its ownK172749 Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2018
Descendant · 5 generations on · 3 of its ownK183401 Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2019

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2009high 2 (2014) · low 0 (2011)2026

Most influential descendants

Showing 5 of 12 · See all

K090371Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization SystemSTERIS Corporation · 2009 · cites it directly9descendants
K140487Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2014 · 2 generations on8descendants
K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2016 · 3 generations on6descendants
K172749Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2018 · 4 generations on5descendants
K183401Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2019 · 5 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K771032	Pouches, Peel Open, Breathable	Surgicot, Inc.	1977	—
0 (this device)	K070765	Vis-U-All II Self Seal Pouch	STERIS Corporation	2007	—
+1	K090371	Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization…	STERIS Corporation	2009	—
+2	K140487	Vis-U-All Low Temperature Sterilization Pouch/Tubing	STERIS Corporation	2014	—
+3	K160908	Vis-U-All Low Temperature Sterilization Pouch/Tubing	STERIS Corporation	2016	—
+4	K172749	Vis-U-All Low Temperature Sterilization Pouch/Tubing	STERIS Corporation	2018	—
+5	K183401	Vis-U-All Low Temperature Sterilization Pouch/Tubing	STERIS Corporation	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2014	2	0
2016	2	0
2018	1	0
2019	2	0
2022	1	0
2023	2	0

FIG. 1 — Lineage of K070765, 1977–2023Source: 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? (2)

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
*	K771032	Pouches, Peel Open, Breathable Summary page 1 …Classification Name: Sterilization wrap (21 CFR 880.6850 Product Code KCT). 2. Predicate Device • Surgicot Pouches, Peel Open, Breathable (K771032) * Surgipeel Self Seal Packaging System (K820302) 3. Description of Device The proposed Vis-U-All Self Se…	Surgicot, Inc.	1977	—
*	K820302	Surgipeel Self-Seal Packaging System Summary page 1 …880.6850 Product Code KCT). 2. Predicate Device • Surgicot Pouches, Peel Open, Breathable (K771032) * Surgipeel Self Seal Packaging System (K820302) 3. Description of Device The proposed Vis-U-All Self Seal Pouch is a Tyvek/plastic film sterilization containm…	Surgicot, Inc.	1982	—
†	K062297	VHP 136 Low Temperature Sterilization System	STERIS Corporation	2007	1

Also cleared against K771032: 1 other device →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K090371	Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization System	STERIS Corporation	2009	9
K092745	Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide, Models: Self and…	STERIS Corporation	2010	1
K141412	Sterilucent Self-Seal Sterilization Pouch	Gs Medical Packaging, Inc.	2014	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?

None of the 2 ancestors has a recall.
Of its descendants, K090371 (STERIS Corporation, 2009) has gone furthest, with 9 descendants of its own.
1 other device also cites its predicate K771032.

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. 2007, this device’s year, is highlighted.

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?

The Vis-U-AIl Self Seal Pouch is a sterilization containment pouch designed for devices to be sterilized by the AMSCO V-Pro 1 Low Temperature Sterilization System. 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 as stated in the FDA summary.

https://510kreport.com/device/K070765 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070765: Vis-U-All II Self Seal Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070765

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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