510(k) · Cleared
ClearedReliance Family of Washer-Disinfectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · LDS Device, Pasteurization, Hot Water
Cleared on May 31, 2000 as substantially equivalent to K911087 (Mdt Biologic Co., 1993) and 1 other predicate after a 637-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- May 31, 2000
- Review
- 637 days
- Class
- Class II
- Product code
- LDS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911087 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK911087 Castle Washer/Disinfector, Model 7550Mdt Biologic Co. · 1993
- This deviceK983068 Reliance Family of Washer-DisinfectorsSTERIS Corporation · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911087 | Castle Washer/Disinfector, Model 7550 | Mdt Biologic Co. | 1993 | — |
| 0 (this device) | K983068 | Reliance Family of Washer-Disinfectors | STERIS Corporation | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 LDS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K911087 | Castle Washer/Disinfector, Model 7550Summary page 1…Name Model 7550 Washer/Disinfector | T-21 Decontaminating Machine Manufacturer MDT/Castle HAMO, USA, Inc. Classification NOT CLASSIFIED NOT CLASSIFIED 510(k) number | K911087 K911120 DEVICE DESCRIPTION The Amsco Reliance Family of Washer/Disinfectors are mechanical, computer- controlled Washer/Disinfe… | 1993 |
| * | K911120 | Decontaminating Machines, LS-850, LS-76, DW/T-216, T-21Summary page 1…odel 7550 Washer/Disinfector | T-21 Decontaminating Machine Manufacturer MDT/Castle HAMO, USA, Inc. Classification NOT CLASSIFIED NOT CLASSIFIED 510(k) number | K911087 K911120 DEVICE DESCRIPTION The Amsco Reliance Family of Washer/Disinfectors are mechanical, computer- controlled Washer/Disinfectors. T… | 1994 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All LDS devicesLDS Device, Pasteurization, Hot Water: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDS
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LDS
Too few LDS 510(k)s in any year since 2007 to give a median.
Recalls per year · LDS
4in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDS
1in 2016
MAUDE reports naming product code LDS, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 4 | 1 |
| 2011 | 0 | — | 0 | 14 |
| 2012 | 0 | — | 0 | 63 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The STERIS Amsco Reliance Family of Washer / Disinfectors are indicated for use in the
cleaning and low-level disinfection of soiled reusable utensils, trays, glassware, bedpans and
urinals, rubber and plastic goods, simple hard-surfaced rigid instruments such as forceps and
clamp, and other similar and related articles found in healthcare facilities.
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/K983068 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983068: Reliance Family of Washer-Disinfectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983068
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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