510(k) · Cleared
ClearedMedical Treatment Chair, T400, T500,T600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care South Asia Pacific Pty, Ltd. · INO Chair, Positioning, Electric
Cleared on Jul 6, 2009 after a 25-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 6, 2009
- Review
- 25 days
- Class
- Class II
- Product code
- INO
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 INO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Convertible© I-Series Positioning and Transfer Chair Named without a submission number |
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.
How does its category compare?
All INO devicesINO Chair, Positioning, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · INO
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · INO
126in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · INO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · INO
29in 2025
MAUDE reports naming product code INO, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 4 | 126 | 0 | 6 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 1 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 23 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 0 | — | 0 | 38 |
| 2019 | 0 | — | 0 | 37 |
| 2020 | 0 | — | 0 | 41 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 0 | — | 1 | 29 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 29 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medical Treatment Chairs are intended for use in medical procedures such as the administration of renal dialysis to, and taking blood from, patients in hospital departments or home use. under the supervision of trained medical staff. The Medical Treatment Chairs are also intended for use In day surgery and nursing homes. The chairs are designed so that the occupant is accommodated In a seated position with the hips moved back so that the occupant's…
Read the full statement (186 words)
The Medical Treatment Chairs are intended for use in medical procedures such as the administration of renal dialysis to, and taking blood from, patients in hospital departments or home use. under the supervision of trained medical staff. The Medical Treatment Chairs are also intended for use In day surgery and nursing homes. The chairs are designed so that the occupant is accommodated In a seated position with the hips moved back so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests.
The chairs are also used to position patients for easy access by healthcare professionals. The chairs are designed so that the occupant is accommodated in a seated position with the hips moved back so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests.
All models are intended to be used by patients with a weight not exceeding:
- 130kg (T100 and T200 series)
- 130kg (T300 and T400 series)
- 200kg (T500, T550, T600 and T650 series)
- 300kg (T500B, T600B)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091727 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091727: Medical Treatment Chair, T400, T500,T600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091727
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026