510(k) · Cleared
ClearedTyvek Sterilization Pouches with Chevron Seal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andersen Sterilizers, Inc. · FRG Wrap, Sterilization
Cleared on Nov 18, 2015 as substantially equivalent to K831425 (Kenpak Converters, Inc., 1983) after a 117-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.
- Decided
- Nov 18, 2015
- Review
- 117 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K831425 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK831425 MDT Chemitest See-Thru BagKenpak Converters, Inc. · 1983
- This deviceK152058 Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK200336 Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK170429 Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831425 | MDT Chemitest See-Thru Bag | Kenpak Converters, Inc. | 1983 | — |
| 0 (this device) | K152058 | Tyvek Sterilization Pouches with Chevron Seal | Andersen Sterilizers, Inc. | 2015 | — |
| +1 | K200336 | Tyvek Sterilization Pouches with Chevron Seal | Andersen Sterilizers, Inc. | 2020 | — |
| +1 | K170429 | Tyvek Sterilization Pouches with Chevron Seal | Andersen Sterilizers, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K831425 | MDT Chemitest See-Thru BagSummary page 5…FRG 5.5 Predicate Device Device Name Tyvek Sterilization Pouches with Chevron Seal 510(k) number K831425 Manufacturer Amcor Flexibles This 510(k) submission modifies the indications for use of the pred… | 1983 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K200336 (Andersen Sterilizers, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The Tyvek Sterilization Pouches with Chevron Seal are intended to be used to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized below in Table 1. Table 1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer…
Read the full statement (176 words)
The Tyvek Sterilization Pouches with Chevron Seal are intended to be used to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.
Critical process parameters for the cycle are summarized below in Table 1.
Table 1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer
EO Amount Temperature Relative Humidity EO Exposure Time Total Cycle Time
17.6 g ± 5% 50°C ± 3°C 35-90% 3 hours 3.5 hours
The 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer has been validated to sterilize a load of up to 24 lbs of metal surgical instruments or 7 lbs of plastic devices (combined weight of pouched devices and tray).
The product codes for Tyvek Sterilization Pouches are listed in Table 2.
Table 2. Product codes for Tyvek Sterilization Pouches
Product Type Self Seal Heat Seal Tubing
Product Codes TLP-030 TLP-031 TLP-033 TLP-058 TLP-059
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152058: Tyvek Sterilization Pouches with Chevron Seal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152058
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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