510(k) · Cleared
ClearedSTERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plasmapp Co,., Ltd. · MLR Sterilizer, Chemical
Cleared on May 9, 2023 as substantially equivalent to K212200 (Plasmapp Co,., Ltd., 2021) after a 222-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- May 9, 2023
- Review
- 222 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K062297 (2007). No later device cites it as a predicate yet.
- Root · 4 generations backK062297 VHP 136 Low Temperature Sterilization SystemSTERIS Corporation · 2007 · Recalled
- 3 generations backK083097 Amsco V-Pro 1 Low Temperature Sterilization SystemSTERIS Corporation · 2009 · Recalled
- 2 generations backK140464 Sterilucent PSD-85 Hydrogen Peroxide SterilizerSterilucent, Inc. · 2014
- 1 generation backK212200 STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassettePlasmapp Co,., Ltd. · 2021
- This deviceK223015 STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassettePlasmapp Co,., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K062297 | VHP 136 Low Temperature Sterilization System | STERIS Corporation | 2007 | 1 |
| −3 | K083097 | Amsco V-Pro 1 Low Temperature Sterilization System | STERIS Corporation | 2009 | 1 |
| −2 | K140464 | Sterilucent PSD-85 Hydrogen Peroxide Sterilizer | Sterilucent, Inc. | 2014 | — |
| −1 | K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | Plasmapp Co,., Ltd. | 2021 | — |
| 0 (this device) | K223015 | STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette | Plasmapp Co,., Ltd. | 2023 | — |
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 MLR? 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 MLR device
- #1 K250802 STERRAD® 100NX Sterilizer with ALLClear™…score 14.0 · 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 |
|---|---|---|---|
| * | K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassetteSummary page 5…s sterilizer with STERPACK plus cassette 510(k) Summary – K223015 The sterilization cycle with STERLOAD™ was cleared under K212200. The focus of this application is on the additional sterilization cycle with STERPACK™ plus. 4. Indications / Intended Use The… | 2021 |
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 16 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K212200.
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MLR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLR
216in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLR
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLR
46in 2025
MAUDE reports naming product code MLR, 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 | 2 | — | 5 | 272 |
| 2008 | 0 | — | 8 | 536 |
| 2009 | 1 | — | 2 | 433 |
| 2010 | 0 | — | 1 | 211 |
| 2011 | 6 | 214 | 2 | 34 |
| 2012 | 2 | — | 3 | 101 |
| 2013 | 1 | — | 9 | 541 |
| 2014 | 2 | — | 3 | 399 |
| 2015 | 1 | — | 0 | 412 |
| 2016 | 4 | 183 | 0 | 286 |
| 2017 | 2 | — | 1 | 279 |
| 2018 | 2 | — | 0 | 289 |
| 2019 | 4 | 90 | 0 | 222 |
| 2020 | 0 | — | 0 | 174 |
| 2021 | 2 | — | 0 | 202 |
| 2022 | 2 | — | 0 | 188 |
| 2023 | 5 | 222 | 0 | 140 |
| 2024 | 3 | 216 | 0 | 44 |
| 2025 | 1 | — | 0 | 46 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The STERLINK™ FPS-15s Plus sterilizer is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture. The STERLINK™ FPS-15s Plus can sterilize*: *…
Read the full statement (182 words)
The STERLINK™ FPS-15s Plus sterilizer is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture.
The STERLINK™ FPS-15s Plus can sterilize*:
* Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
» Medical devices with a single stainless steel lumen with:
o STERPACK™ plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter
o STERLOAD™: An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter
*The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 1 lb and 3.97 lbs with STERPACK™ plus and STERLOAD™, respectively.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223015 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223015: STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223015
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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