510(k) · Cleared
ClearedZephyr 'X-Series Patient Transfer Sled
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diacor, Inc. · FRZ Device, Patient Transfer, Powered
Cleared on Jan 17, 2013 after a 199-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 later devices descend from it.
- Decided
- Jan 17, 2013
- Review
- 199 days
- Class
- Class II
- Product code
- FRZ
- Recalls
- None
- Predicates
- 1
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K121929 | Zephyr 'X-Series Patient Transfer Sled | Diacor, Inc. | 2013 | — |
| +1 | K160627 | Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard… | Qfix | 2016 | — |
| +2 | K230312 | Iris AirShuttle™ | Qfix | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2023 | 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 FRZ? 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K11340 | CIVCO MR & Radiological Patient Positioning Devices Number could not be read Summary page 1…Powered Patient Transfer Device, Product Code FRZ, Regulation Number: 880.6775 (510O(k) Exempt) 2. CIVCO MR & Radiological Patient Positioning Devices - KI 11340 C. Device Description The Zephyr "x-series" Patient Positioning and Transfer System functions as an accessory to su… | |
| * | — | Patient Transfer Systems, Inc., AirPal Platform Powered Patient Transfer Device Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160627 | Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer… | 2016 | 1 |
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?
- Of its descendants, K160627 (Qfix, 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FRZ devicesFRZ Device, Patient Transfer, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FRZ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FRZ
Too few FRZ 510(k)s in any year since 2007 to give a median.
Recalls per year · FRZ
No recall names FRZ since 2007.
Adverse event reports per year · FRZ
3in 2025
MAUDE reports naming product code FRZ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Zephyr "x-series" Patient Positioning and Transfer System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI, and external beam radiation therapy treatment with electrons, photons or protons, as well as other procedures requiring transfer of a patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121929: Zephyr 'X-Series Patient Transfer Sled.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121929
Report an extraction error
Are you the manufacturer?
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