510(k) · Cleared
ClearedPMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std · FRG Wrap, Sterilization
Cleared on Jan 15, 2016 as substantially equivalent to K102158 (Sigma Medical Supplies Corp., 2011) after a 120-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Jan 15, 2016
- Review
- 120 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K990567 (1999). No later device cites it as a predicate yet.
- Root · 5 generations backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
- 4 generations backK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
- 3 generations backK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
- 2 generations backK070428 Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007
- 1 generation backK102158 Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011
- This deviceK152669 PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator…Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990567 | Global Healthcare Self-Sealing Sterilization Pouch | Global Healthcare, Inc. | 1999 | — |
| −4 | K993764 | Medipack See-Through Seal Sterilization Pouch | Medipack Medical Packaging Mfg. Co. | 1999 | — |
| −3 | K051242 | Winner Self Seal Sterilization Pouch | Winner Medical (Usa), Inc. | 2005 | — |
| −2 | K070428 | Medicom Self-Sealing Sterilization Pouch | A.R. Medicom, Inc. | 2007 | — |
| −1 | K102158 | Sigma Sterilization Pouch & Roll | Sigma Medical Supplies Corp. | 2011 | — |
| 0 (this device) | K152669 | PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) | Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std | 2016 | — |
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 |
|---|---|---|---|
| * | K102158 | Sigma Sterilization Pouch & RollSummary page 4…Product Code: 1) FRG 2) JOJ Product Classification: Class II 21 CFR 880.6850, General Hospital (FRG) 21 CFR 880.2800(b), General Hospital (JOJ) 3. Predicate Device K102158, SIGMA Sterilization Pouch and Roll 4. Indications for Use/Intended Use PMSSteripack Self Seal Sterilization Pouches with Chemi… | 2011 |
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 17 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K102158.
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?
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization with steam or ethylene oxide (EO) applying the below validated sterilization cycle parameters. The indicated sterilization parameters for either steam or EO are the only validated sterilization parameters to be used/applied. The recommended (and validated)…
Read the full statement (151 words)
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are intended to provide healthcare workers
with an effective method to enclose medical devices intended for sterilization with steam or ethylene oxide (EO) applying
the below validated sterilization cycle parameters. The indicated sterilization parameters for either steam or EO are the
only validated sterilization parameters to be used/applied.
The recommended (and validated) sterilization cycle parameters are;
• For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes.
• For EO sterilization; 100% ethylene oxide (EO) with a concentration of 725mg/l at 55 degrees C and 50-80% relative
humidity for 60 minutes. Aeration time is 8 hours.
Chemical process indicator on the exterior of the pouch indicates by color change that the pouch has undergone either a
steam or ethylene oxide sterilization process.
After the sterilization process is completed the sterility of the enclosed medical device is maintained for 30 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152669: PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152669
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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