510(k) · Cleared

Cleared

Pouches, Peel Open, Breathable

K771032510(k) TraditionalCleared Jul 14, 197735-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

Surgicot, Inc. · FRG Wrap, Sterilization

Cleared on Jul 14, 1977 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.

Decided: Jul 14, 1977
Review: 35 days
Class: Class II
Product code: FRG
Recalls: None
Predicates: 0

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

This deviceK771032 Pouches, Peel Open, BreathableSurgicot, Inc. · 1977
Descendant · cites it directly · 12 of its ownK070765 Vis-U-All II Self Seal PouchSTERIS Corporation · 2007
Descendant · cites it directly · 11 of its ownK071087 Vis-U-All II Heat-Seal Pouch and TubingSTERIS Corporation · 2007
Descendant · 2 generations on · 9 of its ownK090371 Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1…STERIS Corporation · 2009
Descendant · 3 generations on · 8 of its ownK140487 Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2014
Descendant · 4 generations on · 6 of its ownK160908 Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2016

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2007high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 14 · See all

K070765Vis-U-All II Self Seal PouchSTERIS Corporation · 2007 · cites it directly12descendants
K071087Vis-U-All II Heat-Seal Pouch and TubingSTERIS Corporation · 2007 · cites it directly11descendants
K090371Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization SystemSTERIS Corporation · 2009 · 2 generations on9descendants
K140487Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2014 · 3 generations on8descendants
K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2016 · 4 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K771032	Pouches, Peel Open, Breathable	Surgicot, Inc.	1977	—
+1	K070765	Vis-U-All II Self Seal Pouch	STERIS Corporation	2007	—
+1	K071087	Vis-U-All II Heat-Seal Pouch and Tubing	STERIS Corporation	2007	—
+2	K090371	Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization…	STERIS Corporation	2009	—
+3	K140487	Vis-U-All Low Temperature Sterilization Pouch/Tubing	STERIS Corporation	2014	—
+4	K160908	Vis-U-All Low Temperature Sterilization Pouch/Tubing	STERIS Corporation	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
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 K771032, 1977–2023Source: 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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K070765	Vis-U-All II Self Seal Pouch	STERIS Corporation	2007	12
K071087	Vis-U-All II Heat-Seal Pouch and Tubing	STERIS Corporation	2007	11

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?

Of its descendants, K070765 (STERIS Corporation, 2007) has gone furthest, with 12 descendants of its own.

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	—

https://510kreport.com/device/K771032 · printed Nov 5, 2026

Cite this page

510(k) Report. “K771032: Pouches, Peel Open, Breathable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K771032

Report an extraction error

Are you the manufacturer?

Record history

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