510(k) · Cleared
ClearedSTERLINKTM FPS-15s Plus Sterilizer with STERLOADTM 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 Oct 22, 2021 as substantially equivalent to K140464 (Sterilucent, Inc., 2014) after a 100-day review. Its family tree reaches back 3 generations to 2007. 3 later devices descend from it.
- Decided
- Oct 22, 2021
- Review
- 100 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K062297 (2007). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK062297 VHP 136 Low Temperature Sterilization SystemSTERIS Corporation · 2007 · Recalled
- 2 generations backK083097 Amsco V-Pro 1 Low Temperature Sterilization SystemSTERIS Corporation · 2009 · Recalled
- 1 generation backK140464 Sterilucent PSD-85 Hydrogen Peroxide SterilizerSterilucent, Inc. · 2014
- This deviceK212200 STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassettePlasmapp Co,., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK231169 STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI…Plasmapp Co,., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223015 STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassettePlasmapp Co,., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK220345 STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll…Plasmapp Co,., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd. · 2023 · cites it directly0descendants
- K223015STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassettePlasmapp Co,., Ltd. · 2023 · cites it directly0descendants
- K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K062297 | VHP 136 Low Temperature Sterilization System | STERIS Corporation | 2007 | 1 |
| −2 | K083097 | Amsco V-Pro 1 Low Temperature Sterilization System | STERIS Corporation | 2009 | 1 |
| −1 | K140464 | Sterilucent PSD-85 Hydrogen Peroxide Sterilizer | Sterilucent, Inc. | 2014 | — |
| 0 (this device) | K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | Plasmapp Co,., Ltd. | 2021 | — |
| +1 | K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for… | Plasmapp Co,., Ltd. | 2023 | — |
| +1 | K223015 | STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette | Plasmapp Co,., Ltd. | 2023 | — |
| +1 | K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for… | Plasmapp Co,., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 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 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 |
|---|---|---|---|
| * | K140464 | Sterilucent PSD-85 Hydrogen Peroxide SterilizerSummary page 5…Inc. Device Name FPS-15s Plus PSD-85 510(k) Number K212200 K140464 Device Classification Ethylene oxide gas sterilizer Same Name Classific… | 2014 |
What descends from it? (3)
3 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K231169 (Plasmapp Co,., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K140464.
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 with STERLOAD™ Cassette 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…
Read the full statement (156 words)
The STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ Cassette 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 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 3.97 lbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212200 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212200: STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212200
Report an extraction error
Are you the manufacturer?
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