510(k) · Cleared
ClearedTaiChiB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Our United Corporation · IYE Accelerator, Linear, Medical
Cleared on Nov 2, 2021 as substantially equivalent to K193207 (Our United Corporation, 2020) after a 218-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Nov 2, 2021
- Review
- 218 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K926449 (1995). 38 ancestors in all, the oldest K864886 (1987). No later device cites it as a predicate yet.
- Root · 14 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 10 generations between
- 3 generations backK170817 HalcyonVarian Medical Systems, Inc. · 2017
- 2 generations backK181032 HalcyonVarian Medical Systems, Inc. · 2018
- 1 generation backK193207 TaiChiAOur United Corporation · 2020
- This deviceK210921 TaiChiBOur United Corporation · 2021
Show all 14 generations
- Root · 14 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 13 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 12 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 11 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 10 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 9 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 8 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 7 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 6 generations backK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- 5 generations backK143224 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- 4 generations backK162472 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017
- 3 generations backK170817 HalcyonVarian Medical Systems, Inc. · 2017
- 2 generations backK181032 HalcyonVarian Medical Systems, Inc. · 2018
- 1 generation backK193207 TaiChiAOur United Corporation · 2020
- This deviceK210921 TaiChiBOur United Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −13 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −12 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −11 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −10 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −9 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −8 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −7 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| −6 | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | 2 |
| −5 | K143224 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2014 | 1 |
| −4 | K162472 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2017 | — |
| −3 | K170817 | Halcyon | Varian Medical Systems, Inc. | 2017 | — |
| −2 | K181032 | Halcyon | Varian Medical Systems, Inc. | 2018 | — |
| −1 | K193207 | TaiChiA | Our United Corporation | 2020 | — |
| 0 (this device) | K210921 | TaiChiB | Our United Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K193207 | TaiChiASummary page 4…R 892.5750 Regulatory Class: II Product Code: IYE; IWB III. PREDICATE DEVICE Primary Device TaiChiA Medical Linear Accelerator (K193207) Classification Name: Medical charged-particle radiation therapy system Device Regulation: 21 CFR 892.5050… | 2020 |
| † | K203250 | TaiChiC | 2021 |
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?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 26 of the 38 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
TaiChiB Digital Radiotherapy System is a teletherapy device equipped with two radiation beam delivery units within an enclosed gantry.
(1) The electron linear accelerator producing 6MV photon beam is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
(2) The rotating focused gamma beam emitting unit with multiple Cobalt-60 sources is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.
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/K210921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210921: TaiChiB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210921
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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