510(k) · Cleared
ClearedLOWTEM Crystal 120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lowtem Co., Ltd. · MLR Sterilizer, Chemical
Cleared on Sep 18, 2024 as substantially equivalent to K062297 (STERIS Corporation, 2007) and 1 other predicate after a 448-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Sep 18, 2024
- Review
- 448 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K020875 (2003). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 3 generations backK051595 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006
- 2 generations backK090636 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2009
- 1 generation backK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- This deviceK231893 LOWTEM Crystal 120Lowtem Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020875 | TSO3 Ozone Sterilizer, Model 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003 | — |
| −3 | K051595 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2006 | — |
| −2 | K090636 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2009 | — |
| −1 | K102330 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| 0 (this device) | K231893 | LOWTEM Crystal 120 | Lowtem Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K062297 | VHP 136 Low Temperature Sterilization SystemSummary page 5…sification: Class II Review Panel: General Hospital Predicate Devices: Amsco® V-PROTM 1 Low Temperature Sterilization System – K062297 Amsco® V-PROTM MAX Low Temperature Sterilization System – K102330 3. Device Description The LOWTEM Crystal 120 low-tem… | 2007 |
| * | K102330 | Amsco V-Pro Max Low Temperature Sterilization SystemSummary page 5…al Hospital Predicate Devices: Amsco® V-PROTM 1 Low Temperature Sterilization System – K062297 Amsco® V-PROTM MAX Low Temperature Sterilization System – K102330 3. Device Description The LOWTEM Crystal 120 low-temperature vaporized hydrogen peroxide sterilizer is a self- contained st… | 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 21 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 7 other devices also cite its predicate K062297.
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 LOWTEM Crystal 120 Sterilizer System is indicated to sterilize pre-cleaned and dried reusable medical devices with nonabsorbable materials. The Crystal 120 sterilizer’s Standard cycle can sterilize: * Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors, * Medical devices with single stainless-steel lumen with: An inside diameter of 1mm or larger and a length of 125mm or shorter An inside diameter of 2mm or…
Read the full statement (212 words)
The LOWTEM Crystal 120 Sterilizer System is indicated to sterilize pre-cleaned and dried reusable medical devices with nonabsorbable materials. The Crystal 120 sterilizer’s Standard cycle can sterilize:
* Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors,
* Medical devices with single stainless-steel lumen with:
An inside diameter of 1mm or larger and a length of 125mm or shorter
An inside diameter of 2mm or larger and a length of 250mm or shorter
An inside diameter of 3mm or larger and a length of 400mm or shorter
※ The validation testing for this lumen size was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
- Contra-indication: It is contraindicated to sterilize single usable medical devices and devices made up with absorbable materials such as cellulose or wood.
- Intended user: trained nurse level or higher level of healthcare providers
The validated maximum load conditions
Total weight:
The validation performances were conducted using a validation load consisting of two instrument trays containing a total weight of 8.9kg(19.6lbs).
Usage of sterilization pouch:
The medical devices to be sterilized are packaged in Tyvek sterilization pouch and sealed. The pouched medical devices are placed at the trays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231893: LOWTEM Crystal 120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231893
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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