510(k) · Cleared
ClearedSterilucent HC 80TT 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 Sep 13, 2019 as substantially equivalent to K140464 (Sterilucent, Inc., 2014) after a 254-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Sep 13, 2019
- Review
- 254 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K062297 (2007). No later device cites it as a predicate yet.
- 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 deviceK190005 Sterilucent HC 80TT Hydrogen Peroxide SterilizerSterilucent, Inc. · 2019
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) | K190005 | Sterilucent HC 80TT Hydrogen Peroxide Sterilizer | Sterilucent, Inc. | 2019 | — |
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…21 CFR 880.6860 Class: II Product Code: MLR Predicate Device(s): Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (K140464) Device Description: The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (HC 80TT) is… | 2014 |
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 12 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 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. 2019, 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 HC 80TT Hydrogen Peroxide 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. The two pre-programmed sterilization cycles, the Lumen Cycle and the Flexible Cycle, operate at low pressure and low temperature and are thus suitable for processing medical devices that are sensitive to heat…
Read the full statement (305 words)
The Sterilucent HC 80TT Hydrogen Peroxide 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. The two pre-programmed sterilization cycles, the Lumen Cycle and the Flexible Cycle, operate at low pressure and low temperature and are thus suitable for processing medical devices that are sensitive to heat and moisture.
The HC 80TT Lumen Cycle can sterilize:
o Lumen and non-lumen medical devices with diffusion-restricted spaces or mated surfaces such as the hinged portion of forceps and scissors;
o Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel Iumens that are:
• 2: 0.77 mm internal diameter(ID) and :S 410 mm long, or
• 2: 1.33 mm ID and :S 430 mm long; and,
o Triple channeled rigid and semi-rigid endoscopes, with stainless steel Iumens that are:
• 2: 1.00 mm ID and :S 310 mm long.
The validation testing for all lumen sizes was conducted using a maximum of fifteen (15) Iumens per load.
Hospital loads should not exceed the maximum number oflumens validated by this testing. The validation
studies were performed using two (2) separate validation loads as described in the following table.
1 Excluding the weight of the wrap.
The HC 80TT Flexible Cycle can sterilize:
• Rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion-restricted spaces such or mated
surfaces such as the hinged portion of forceps or scissors;
• Single channel flexible endoscopes with flexible Iumens that are:
• 2: 1.00 mm ID and :S 1280 mm long; and,
• Dual channel flexible endoscopes with flexible Iumens that are:
• 2: 0.80 mm ID and :S 1000 mm long.
The validation studies were performed using four (4) separate validation loads as described in the following table.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190005: Sterilucent HC 80TT Hydrogen Peroxide Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190005
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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