510(k) · Cleared
ClearedEndoscopic CO2 Regulation Unit Ucr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Dec 23, 2008 as substantially equivalent to K053382 (Olympus Medical Systems Corporation, 2006) after a 243-day review. Its family tree reaches back 3 generations to 1993. 4 later devices descend from it.
- Decided
- Dec 23, 2008
- Review
- 243 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923982 (1993). 7 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK923982 Olympus Oes Laparoscopy SystemOlympus Corp. · 1993 · Recalled
- 2 generations backK955403 Oes Laparo-Thoraco Videoscope Type VOlympus America, Inc. · 1996
- 1 generation backK053382 Laparo-Thoraco Videoscope XLTF-VawOlympus Medical Systems Corporation · 2006
- This deviceK081173 Endoscopic CO2 Regulation Unit UcrOlympus Medical Systems Corporation · 2008
- Descendant · cites it directly · 3 of its ownK111648 Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK201096 CO2mbiLEDKarl Storz Endoscopy America, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK190985 BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK162332 Nexcore GI InsufflatorNexcore Technology, LLC · 2016
Most influential descendants
Showing 4 of 4 · See all- K111648Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc. · 2011 · cites it directly3descendants
- K201096CO2mbiLEDKarl Storz Endoscopy America, Inc. · 2020 · 2 generations on0descendants
- K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc. · 2019 · 2 generations on0descendants
- K162332Nexcore GI InsufflatorNexcore Technology, LLC · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923982 | Olympus Oes Laparoscopy System | Olympus Corp. | 1993 | 1 |
| −2 | K955403 | Oes Laparo-Thoraco Videoscope Type V | Olympus America, Inc. | 1996 | — |
| −1 | K053382 | Laparo-Thoraco Videoscope XLTF-Vaw | Olympus Medical Systems Corporation | 2006 | — |
| 0 (this device) | K081173 | Endoscopic CO2 Regulation Unit Ucr | Olympus Medical Systems Corporation | 2008 | — |
| +1 | K111648 | Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator | Bracco Diagnostic, Inc. | 2011 | 1 |
| +2 | K201096 | CO2mbiLED | Karl Storz Endoscopy America, Inc. | 2020 | — |
| +2 | K190985 | BAROnova Insufflation System, BAROnova Accessory Kit | Baronova, Inc. | 2019 | — |
| +2 | K162332 | Nexcore GI Insufflator | Nexcore Technology, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 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 |
|---|---|---|---|
| * | K053382 | Laparo-Thoraco Videoscope XLTF-VawSummary page 2…MAJ-1203 Air/Vater Supply Pump Unit Common Name: Air/Water Supply Pump Unit 510(k) No. Part of submission of K053382 Manufacturer: Olympus Optical Co., Ltd. 4 Device Description The subject UCR Endoscopic… | 2006 |
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 |
|---|---|---|---|
| K111648 | Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator | 2011 | 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 15 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K111648 (Bracco Diagnostic, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K053382.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This instrument has been designed to be used with Olympus XLTF-VAW Laparo-Thoraco Videoscope and other ancillary equipment for CO 2 gas and water feeding to clean the distal lens during endoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081173 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081173: Endoscopic CO2 Regulation Unit Ucr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081173
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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