510(k) · Cleared
ClearedRAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · NVE Washer, Cleaner, Automated, Endoscope
Cleared on Aug 21, 2019 as substantially equivalent to K073112 (Intuitive Surgical, Inc., 2008) after a 217-day review. Its family tree reaches back 11 generations to 1994. 4 later devices descend from it.
- Decided
- Aug 21, 2019
- Review
- 217 days
- Class
- Class II
- Product code
- NVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K930667 (1994). 47 ancestors in all, the oldest K811390 (1981). 4 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 7 generations between
- 3 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 2 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 1 generation backK073112 DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc. · 2008
- This deviceK190081 RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP…STERIS Corporation · 2019
- Descendant · cites it directly · 3 of its ownK200577 RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP…STERIS Corporation · 2020
- Descendant · 2 generations on · 2 of its ownK203199 RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP /…STERIS Corporation · 2020
- Descendant · 3 generations on · 1 of its ownK222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022
- Descendant · 4 generations on · 0 of its ownK222849 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022
Show all 11 generations
- Root · 11 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 10 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 9 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 8 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 7 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 6 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 5 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 4 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 3 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 2 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 1 generation backK073112 DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc. · 2008
- This deviceK190081 RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP…STERIS Corporation · 2019
Most influential descendants
Showing 4 of 4 · See all- K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation · 2020 · cites it directly3descendants
- K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single…STERIS Corporation · 2020 · 2 generations on2descendants
- K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · 3 generations on1descendant
- K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −10 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −9 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −8 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −7 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −6 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −5 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −4 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −3 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −2 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −1 | K073112 | DA Vinci Sonicpro Cleaning System, Model 400253 | Intuitive Surgical, Inc. | 2008 | — |
| 0 (this device) | K190081 | RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber… | STERIS Corporation | 2019 | — |
| +1 | K200577 | RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single… | STERIS Corporation | 2020 | — |
| +2 | K203199 | RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP… | STERIS Corporation | 2020 | — |
| +3 | K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System… | Steris | 2022 | — |
| +4 | K222849 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System… | Steris | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 2 | 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 NVE? 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 NVE device
- #1 K222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low…score 10.8 · 14 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 |
|---|---|---|---|
| * | K073112 | DA Vinci Sonicpro Cleaning System, Model 400253Summary page 5…, automated Classification Number: 21 CFR 876.1500 Product Code: NVE 2. Predicate Device da Vinci SonicPro Cleaning System: K073112 3. Device Description The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200577 | RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber… | 2020 | 3 |
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 25 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 47 ancestors have a recall of any class.
- Of its descendants, K200577 (STERIS Corporation, 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NVE devicesNVE Washer, Cleaner, Automated, Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NVE
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · NVE
Too few NVE 510(k)s in any year since 2007 to give a median.
Recalls per year · NVE
No recall names NVE since 2007.
Adverse event reports per year · NVE
1in 2025
MAUDE reports naming product code NVE, 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 | 0 |
| 2008 | 1 | — | 0 | 20 |
| 2009 | 0 | — | 0 | 219 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RAS Racks are used in the RAS Cycles of AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors for the effective cleaning, rinsing, drying and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190081: RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190081
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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