510(k) Report

510(k) · Cleared

Cleared

Vis-U-All Low Temperature Sterilization Pouch/Tubing

K140487510(k) TraditionalCleared Jul 22, 2014145-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 Jul 22, 2014 as substantially equivalent to K090371 (STERIS Corporation, 2009) after a 145-day review. Its family tree reaches back 3 generations to 1977. 8 later devices descend from it.

Decided
Jul 22, 2014
Review
145 days
Class
Class II
Product code
FRG
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K771032 (1977). 6 ancestors in all. 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor1995: 1 other ancestor1982: 1 other ancestor2016: 2 descendants cleared2018: 1 descendant cleared2019: 2 descendants cleared2022: 1 descendant cleared2023: 2 descendants clearedK771032 · Pouches, Peel Open, Breathable · Surgicot, Inc. · 1977K070765 · Vis-U-All II Self Seal Pouch · STERIS Corporation · 2007K090371 · Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization System · STERIS Corporation · 200919801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 2 descendants K090371 · Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization System · STERIS Corporation · 2009K070765 · Vis-U-All II Self Seal Pouch · STERIS Corporation · 2007K771032 · Pouches, Peel Open, Breathable · Surgicot, Inc. · 19770+5
  1. Root · 3 generations backK771032 Pouches, Peel Open, BreathableSurgicot, Inc. · 1977
  2. 2 generations backK070765 Vis-U-All II Self Seal PouchSTERIS Corporation · 2007
  3. 1 generation backK090371 Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1…STERIS Corporation · 2009
  4. This deviceK140487 Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2014
  5. Descendant · cites it directly · 6 of its ownK160908 Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2016
  6. Descendant · 2 generations on · 5 of its ownK172749 Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2018
  7. Descendant · 3 generations on · 3 of its ownK183401 Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2019
  8. Descendant · 4 generations on · 2 of its ownK222440 Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE…Steris · 2022
  9. Descendant · 5 generations on · 0 of its ownK231501 PRO-LITE Sterilization TraySTERIS Corporation · 2023

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2016: 22018: 12019: 22022: 12023: 2
2016high 2 (2016) · low 0 (2017)2026

Most influential descendants

Showing 5 of 8 · See all
  • K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2016 · cites it directly6descendants
  • K172749Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2018 · 2 generations on5descendants
  • K183401Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2019 · 3 generations on3descendants
  • K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris · 2022 · 4 generations on2descendants
  • K231501PRO-LITE Sterilization TraySTERIS Corporation · 2023 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K771032Pouches, Peel Open, BreathableSurgicot, Inc.1977—
−2K070765Vis-U-All II Self Seal PouchSTERIS Corporation2007—
−1K090371Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization…STERIS Corporation2009—
0 (this device)K140487Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation2014—
+1K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation2016—
+2K172749Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation2018—
+3K183401Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation2019—
+4K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization…Steris2022—
+5K231501PRO-LITE Sterilization TraySTERIS Corporation2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
199510
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
201810
201920
202210
202320
FIG. 1 — Lineage of K140487, 1977–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K090371Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization System
Summary page 2
…Classification Name: Sterilization wrap (21 CFR 880.6850 Product Code FRG). Class 11 2. Predicate Devices K090371 - Vis-U-AII Low Temperature Tyvek Sterilization Pouch for V-PRO I Sterilization System 3. Description of Device Th…
STERIS Corporation2009—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20166
K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti20160

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?

  • The line of descent spans 37 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K160908 (STERIS Corporation, 2016) has gone furthest, with 6 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. 2014, this device’s year, is highlighted.

FDA decisions per year · FRG

9in 2025

2007: 32008: 22009: 42010: 42011: 62012: 102013: 62014: 82015: 122016: 92017: 92018: 52019: 92020: 52021: 42022: 92023: 92024: 112025: 92026 (partial year): 4
2007high 12 (2015) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRG

151in 2025

2007: 182 days median2009: 171 days median2010: 213 days median2011: 110 days median2012: 133 days median2013: 146 days median2014: 177 days median2015: 196 days median2016: 131 days median2017: 260 days median2018: 150 days median2019: 258 days median2020: 122 days median2021: 170 days median2022: 217 days median2023: 230 days median2024: 182 days median2025: 151 days median2026 (partial year): 247 days median
2007high 260 (2017) · low 110 (2011)2026

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

Recalls per year · FRG

2in 2022

2013: 22017: 292020: 142022: 2
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

2007: 12008: 22009: 22011: 122012: 42013: 52014: 132015: 92016: 202017: 72018: 222019: 102020: 212021: 92022: 42023: 132024: 212025: 18
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007318201
20082—02
2009417102
2010421300
20116110012
20121013304
2013614625
20148177013
20151219609
20169131020
20179260297
20185150022
20199258010
202051221421
2021417009
2022921724
20239230013
202411182021
20259151018
202642470—

What is it indicated for?

The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose medical devices to be sterilized in Lumen and Non Lumen Cycles in the V-PRO 60 Low Temperature Sterilization System. The pouches are intend to maintain the sterility of the enclosed devices until used. Pouches are intended to contain devices in such a manner as to leave a minimum of one inch between the devices and…

Read the full statement (146 words)

The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose medical devices to be sterilized in Lumen and Non Lumen Cycles in the V-PRO 60 Low Temperature Sterilization System. The pouches are intend to maintain the sterility of the enclosed devices until used.

Pouches are intended to contain devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. Devices with stainless steel lumens and the following minimum internal diameter (ID) and maximum length can be processed in Vis-U-All Low Temperature Sterilization Pouch/Tubing using the Lumen Cycle.

single or dual lumen devices

0.77 mm ID and 410 mm in length

triple lumen devices

1.2 mm ID and 275 mm in length

1.8 mm ID and 310 mm in length

or

2.8 mm ID and 317 mm in length

Indications for use as stated in the FDA summary.

More from STERIS Corporation

205 FDA decisions under this applicant name. See the company

  • K261055AMSCO 700 Steam SterilizerSTERIS Corporation · 2026
  • K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant…STERIS Corporation · 2026
  • K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation · 2026
  • K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation · 2025
  • K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation · 2025

Recent decisions in FRG

The FRG category page

  • K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap…O&M Halyard, Inc. · 2026
  • K252823Dukal Crepe Paper Sterilization WrapDukal, LLC · 2026
  • K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL…O&M Halyard, Inc. · 2026
  • K251347Sterilization Pouch/RollSterivic Medical Co., Ltd. · 2026
  • K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd. · 2025

https://510kreport.com/device/K140487 · printed Nov 3, 2026

Cite this page

510(k) Report. “K140487: Vis-U-All Low Temperature Sterilization Pouch/Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K140487

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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