510(k) · Cleared
ClearedPMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti · FRG Wrap, Sterilization
Cleared on Nov 18, 2016 as substantially equivalent to K140487 (STERIS Corporation, 2014) after a 262-day review. Its family tree reaches back 4 generations to 1977.
- Decided
- Nov 18, 2016
- Review
- 262 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K771032 (1977). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK771032 Pouches, Peel Open, BreathableSurgicot, Inc. · 1977
- 3 generations backK070765 Vis-U-All II Self Seal PouchSTERIS Corporation · 2007
- 2 generations backK090371 Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1…STERIS Corporation · 2009
- 1 generation backK140487 Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation · 2014
- This deviceK160595 PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with…Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K771032 | Pouches, Peel Open, Breathable | Surgicot, Inc. | 1977 | — |
| −3 | K070765 | Vis-U-All II Self Seal Pouch | STERIS Corporation | 2007 | — |
| −2 | K090371 | Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization… | STERIS Corporation | 2009 | — |
| −1 | K140487 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | STERIS Corporation | 2014 | — |
| 0 (this device) | K160595 | PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical… | Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1995 | 1 | 0 |
| 2007 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140487 | Vis-U-All Low Temperature Sterilization Pouch/TubingSummary page 6…icator, Physical/Chemical Sterilization Process Product Code: FRG Product Classification: Class II, 21 CFR 880.6850, General Hospital (FRG) 3. Predicate Device K140487, STERIS Vis-U-All Low Temperature Sterilization Pouch/Tubing 4.Indications for use PMS Steripack Tyvek Sterilization Pouches (T… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K140487.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FRG
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 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?
PMS Steripack Tyvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator; are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization in vaporized hydrogen peroxide (VHP) sterilization method. PMS Steripack Tyvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator is a device intended to be used to enclose another medical device that is to be sterilized by a…
Read the full statement (296 words)
PMS Steripack Tyvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator; are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization in vaporized hydrogen peroxide (VHP) sterilization method.
PMS Steripack Tyvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical devices and also maintain sterility of the enclosed devices until used.
The recommended (and validated) sterilization cycle parameters are:
The Steris V-PRO 1 PLUS LUMEN CYCLE is a single preprogramed standard sterilization cycle with NO cycle parameter variables allowed by the end user.
Chemical process indicator on the exterior of the Tyvek pouches and rolls indicates that the pouch has been exposed to V-PRO 1 Plus, Lumen Cycle sterilization process by changing color from red to blue or (lighter).
Devices with stainless steel lumens with the following internal diameter (ID) and maximum length can be processed in V-PRO 1 Plus, Lumen Cycle.
Table 1. Lumen Claims
Pouch Size: 50 x 200mm; Max. lumen length: 50 mm; Min. internal diameter: 1.5 mm; Max # Lumens: 1
Pouch Size: 150 x 300mm; Max. lumen length: 3 mm; Min. internal diameter: 200 mm; Max # Lumens: 1
Pouch Size: 350 x 600mm; Max. lumen length: 3 mm; Min. internal diameter: 400 mm; Max # Lumens: 1
Worst Case Load:
The worst case load for the 50 mm x 200 mm pouch is 0.058 lbs. of instruments.
The worst case load for the 150 mm x 300 mm pouch is 0.630 lbs. of instruments.
The worst case load for the 350 mm x 600 mm pouch is 3.054 lbs. of instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160595: PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160595
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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