510(k) · Cleared
ClearedSterilucent PSD-85 Hydrogen Peroxide Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilucent, Inc. · MLR Sterilizer, Chemical
Cleared on Oct 31, 2014 as substantially equivalent to K083097 (STERIS Corporation, 2009) after a 249-day review. Its family tree reaches back 2 generations to 2007. 5 later devices descend from it.
- Decided
- Oct 31, 2014
- Review
- 249 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K062297 (2007). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK062297 VHP 136 Low Temperature Sterilization SystemSTERIS Corporation · 2007 · Recalled
- 1 generation backK083097 Amsco V-Pro 1 Low Temperature Sterilization SystemSTERIS Corporation · 2009 · Recalled
- This deviceK140464 Sterilucent PSD-85 Hydrogen Peroxide SterilizerSterilucent, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK212200 STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassettePlasmapp Co,., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK231169 STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI…Plasmapp Co,., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK223015 STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassettePlasmapp Co,., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK220345 STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll…Plasmapp Co,., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK190005 Sterilucent HC 80TT Hydrogen Peroxide SterilizerSterilucent, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K212200STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassettePlasmapp Co,., Ltd. · 2021 · cites it directly3descendants
- K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd. · 2023 · 2 generations on0descendants
- K223015STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassettePlasmapp Co,., Ltd. · 2023 · 2 generations on0descendants
- K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd. · 2023 · 2 generations on0descendants
- K190005Sterilucent HC 80TT Hydrogen Peroxide SterilizerSterilucent, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K062297 | VHP 136 Low Temperature Sterilization System | STERIS Corporation | 2007 | 1 |
| −1 | K083097 | Amsco V-Pro 1 Low Temperature Sterilization System | STERIS Corporation | 2009 | 1 |
| 0 (this device) | K140464 | Sterilucent PSD-85 Hydrogen Peroxide Sterilizer | Sterilucent, Inc. | 2014 | — |
| +1 | K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | Plasmapp Co,., Ltd. | 2021 | — |
| +2 | K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for… | Plasmapp Co,., Ltd. | 2023 | — |
| +2 | K223015 | STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette | Plasmapp Co,., Ltd. | 2023 | — |
| +2 | K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for… | Plasmapp Co,., Ltd. | 2023 | — |
| +1 | K190005 | Sterilucent HC 80TT Hydrogen Peroxide Sterilizer | Sterilucent, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K083097 | Amsco V-Pro 1 Low Temperature Sterilization SystemSummary page 5…FDA Classification Number: 880.6860 Product Code: MLR Predicate Device AMSCO® V-PRO™ 1 Plus Low Temperature Sterilization System (K083097) Device Description The Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (PSD-85) is a self contained stand alone d… | 2009 |
What descends from it? (5)
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K212200 (Plasmapp Co,., Ltd., 2021) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K083097.
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (PSD-85) 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. The two pre-programmed sterilization cycles, the Lumen and the Non-Lumen Cycles, operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and…
Read the full statement (247 words)
The Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (PSD-85) 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. The two pre-programmed sterilization cycles, the Lumen and the Non-Lumen Cycles, operate at low
pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The PSD-85 Lumen Cycle 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 1 mm or larger and a length of 60 mm or shorter
o An inside diameter of 2 mm or larger and a length of 250 mm or shorter
o An inside diameter of 3 mm or larger and a length of 350 mm or shorter
*The validation testing for all lumen sizes was conducted using a maximum of ten (10) 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 consisting of one instrument tray with a total weight of 10.4 lbs.
The PSD-85 Non-Lumen Cycle can sterilize**:
• Non-lumen instruments including non-lumen instruments with stainless steel diffusion-restricted areas such as the
hinged portion of forceps or scissors.
**The validation studies were conducted using a validation load consisting of one instrument tray with a total weight of
25.3 lbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140464 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140464: Sterilucent PSD-85 Hydrogen Peroxide Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140464
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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