510(k) · Cleared

Cleared

Vis-U-All II Heat-Seal Pouch and Tubing

K071087510(k) TraditionalCleared Oct 16, 2007182-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 · FRG Wrap, Sterilization

Cleared on Oct 16, 2007 as substantially equivalent to K951295 (Advanced Sterilization Products, 1995) and 1 other predicate after a 182-day review. Its family tree reaches back 1 generation to 1977. 11 later devices descend from it.

Decided: Oct 16, 2007
Review: 182 days
Class: Class II
Product code: FRG
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K771032 (1977). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK771032 Pouches, Peel Open, BreathableSurgicot, Inc. · 1977
This deviceK071087 Vis-U-All II Heat-Seal Pouch and TubingSTERIS 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 11 descendants. See all descendants

Descendants cleared per year

2009high 2 (2016) · low 0 (2011)2026

Most influential descendants

Showing 5 of 11 · 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)	K071087	Vis-U-All II Heat-Seal Pouch and Tubing	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
1995	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K071087, 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 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? (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
*	K951295	Sterrad Sterilization Pouch Summary page 1 …ilization pouch Classification Name: Sterilization wrap (21 CFR 880.6850 Product Code KCT). 2. Predicate Devices * Sterrad Sterilization Pouch (K951295) * Surgicot Pouches, Peel Open, Breathable (K771032) 3. Description of Device The proposed Vis-U-All 1-leat S…	Advanced Sterilization Products	1995	1
*	K771032	Pouches, Peel Open, Breathable Summary page 1 …wrap (21 CFR 880.6850 Product Code KCT). 2. Predicate Devices * Sterrad Sterilization Pouch (K951295) * Surgicot Pouches, Peel Open, Breathable (K771032) 3. Description of Device The proposed Vis-U-All 1-leat Seal Pouch is a Tyvek/plastic film sterilization containme…	Surgicot, Inc.	1977	—

Also cleared against K951295: 1 other device →

What descends from it? (11)

See all 11

2 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

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K090371 (STERIS Corporation, 2009) has gone furthest, with 9 descendants of its own.
1 other device also cites its predicate K951295.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Vis-U-All Heat-Seal Pouch and Tubing have been qualified by STERIS Corporation

as suitable for use by health care providers to enclose and seal other medical devices to

be sterilized in the AMSCO V-Pro 1 Low Temperature Sterilizer. The system is designed

to maintain sterility of properly processed medical devices during normal handling and

storage until the pouch is opened and the medical device is removed for use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071087 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071087: Vis-U-All II Heat-Seal Pouch and Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071087

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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