510(k) · Cleared
ClearedGUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pci Medical, Inc. · PSW High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
Cleared on Nov 16, 2015 as substantially equivalent to K051305 (Cs Medical, LLC, 2005) after a 263-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Nov 16, 2015
- Review
- 263 days
- Class
- Class II
- Product code
- PSW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914145 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
- 1 generation backK051305 CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100…Cs Medical, LLC · 2005
- This deviceK150504 GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR…Pci Medical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK163313 ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR…CIVCO Medical Instruments Co., Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe…CIVCO Medical Instruments Co., Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914145 | DSD-91(TM) Disinfector for Flexible Endoscopes | Medivators, Inc. | 1994 | 1 |
| −1 | K051305 | CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical… | Cs Medical, LLC | 2005 | — |
| 0 (this device) | K150504 | GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR… | Pci Medical, Inc. | 2015 | — |
| +1 | K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal… | CIVCO Medical Instruments Co., Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 PSW? 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 PSW device
- #1 K233049 TD 200® Automated TEE Probe Disinfector with…score 7.9 · 6 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 |
|---|---|---|---|
| * | K051305 | CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5…Summary page 5…me Diagnostic Ultrasonic Transducer, 21 CFR 892.1570 Classification Class Il Product Code ITX Predicate Device(s) CS MEDICAL TD-100 Transesophageal Probe Disinfector, K051305 Intended Use cilitates high-level disinfection and rinsing of 1 or 2 transesophageal ultrasound probes using FDA cleared and PC… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe… | 2017 | 0 |
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 3 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K163313 (CIVCO Medical Instruments Co., Inc., 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K051305.
How does its category compare?
All PSW devicesPSW High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PSW
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PSW
Too few PSW 510(k)s in any year since 2007 to give a median.
Recalls per year · PSW
No recall names PSW since 2007.
Adverse event reports per year · PSW
No MAUDE report names PSW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GUS ASTRA TEE™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transesophageal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.
The GUS ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal and/or endorectal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.
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/K150504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150504: GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150504
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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