510(k) · Cleared
ClearedANDORATE® Suction Valve and ANDORATE® Biopsy Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ga Health Company Limited · KTI Bronchoscope Accessory
Cleared on May 11, 2023 as substantially equivalent to K061313 (Olympus Medical Systems Corporation, 2006) after a 99-day review. Its family tree reaches back 7 generations to 1993. 2 of the 22 devices in its family, counting itself, have a Class I recall.
- Decided
- May 11, 2023
- Review
- 99 days
- Class
- Class II
- Product code
- KTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K931154 (1993). 21 ancestors in all, the oldest K850978 (1985). No later device cites it as a predicate yet. 2 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 5 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 4 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 3 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 2 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 1 generation backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- This deviceK230280 ANDORATE® Suction Valve and ANDORATE® Biopsy ValveGa Health Company Limited · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −6 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −5 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −4 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −3 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −2 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −1 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| 0 (this device) | K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | Ga Health Company Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 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.
2 devices in this family have a Class I recall. 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 KTI device
- #1 K261274 EchoTip Ultra® Endobronchial HD Ultrasound…score 15.0 · 12 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 |
|---|---|---|---|
| * | K061313 | Evis Exera 180 SystemSummary page 4…Regulation Class: 2 Device Panel: Ear Nose & Throat 5. Predicate Device Identification Predicate Device 510(k) No.: K061313 Predicate Device Trade Name: EVIS EXERA II 180 System… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Direct predicate · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 12 of the 21 ancestors have a recall of any class; 2 have a Class I recall.
- 9 other devices also cite its predicate K061313.
How does its category compare?
All KTI devicesKTI Bronchoscope Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · KTI
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTI
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTI
198in 2025
MAUDE reports naming product code KTI, 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 | 3 |
| 2008 | 1 | — | 0 | 11 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 17 |
| 2012 | 0 | — | 1 | 12 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 3 | 140 | 0 | 7 |
| 2017 | 3 | 115 | 0 | 9 |
| 2018 | 1 | — | 1 | 14 |
| 2019 | 1 | — | 0 | 27 |
| 2020 | 1 | — | 0 | 37 |
| 2021 | 1 | — | 0 | 47 |
| 2022 | 3 | 137 | 0 | 131 |
| 2023 | 4 | 168 | 0 | 130 |
| 2024 | 0 | — | 0 | 149 |
| 2025 | 5 | 61 | 0 | 198 |
| 2026 | 3 | 98 | 0 | — |
What is it indicated for?
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during the endoscopic procedure.
The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230280: ANDORATE® Suction Valve and ANDORATE® Biopsy Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230280
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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