510(k) · Cleared
ClearedNurse's Aid Patient Rotation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air Med Assist Products · IOQ Bed, Flotation Therapy, Powered
Cleared on Jan 21, 1998 as substantially equivalent to K931594 (Medical Device Inspection Co., Inc., 1993) after a 120-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jan 21, 1998
- Review
- 120 days
- Class
- Class II
- Product code
- IOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K931594 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK931594 Thera-Turn CM-1000 Mattress Overlay SystemMedical Device Inspection Co., Inc. · 1993
- This deviceK973624 Nurse's Aid Patient Rotation SystemAir Med Assist Products · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931594 | Thera-Turn CM-1000 Mattress Overlay System | Medical Device Inspection Co., Inc. | 1993 | — |
| 0 (this device) | K973624 | Nurse's Aid Patient Rotation System | Air Med Assist Products | 1998 | — |
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 IOQ? 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 |
|---|---|---|---|
| * | K931594 | Thera-Turn CM-1000 Mattress Overlay SystemSummary page 1…Page 1 === La 73624 SUMMARY OF SAFETY AND EFFECTIVENESS JAN 2 | 1998 01. DEVICE NAME (Trade, common, and classification): Flotation mattress. 02. PREDICATE DEVICE(s): K931594 and K933091 submissions, attached, which were determined to be SE, and several others. 03. DESCRIPTION: An air-flotation, altern… | 1993 |
| Kept off the family tree | K933091 | FDA’s K933091 is Stage IV, CM-4000,Mattress Overlay System Our OCR of the scanned summary read K933091, FDA’s number for Stage IV, CM-4000,Mattress Overlay System (Creative Medical, Inc.), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 1…a 73624 SUMMARY OF SAFETY AND EFFECTIVENESS JAN 2 | 1998 01. DEVICE NAME (Trade, common, and classification): Flotation mattress. 02. PREDICATE DEVICE(s): K931594 and K933091 submissions, attached, which were determined to be SE, and several others. 03. DESCRIPTION: An air-flotation, alternating pressu… | 1993 |
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?
- Its one ancestor has no recall.
How does its category compare?
All IOQ devicesIOQ Bed, Flotation Therapy, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IOQ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · IOQ
Too few IOQ 510(k)s in any year since 2007 to give a median.
Recalls per year · IOQ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IOQ
142in 2025
MAUDE reports naming product code IOQ, 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 | 7 |
| 2008 | 0 | — | 1 | 10 |
| 2009 | 0 | — | 4 | 35 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 0 | — | 1 | 9 |
| 2013 | 1 | — | 1 | 15 |
| 2014 | 0 | — | 0 | 35 |
| 2015 | 1 | — | 0 | 28 |
| 2016 | 0 | — | 0 | 42 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 0 | — | 0 | 20 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 56 |
| 2022 | 0 | — | 2 | 22 |
| 2023 | 0 | — | 1 | 111 |
| 2024 | 0 | — | 0 | 392 |
| 2025 | 0 | — | 0 | 142 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
This device is used to provide cushioning, torso support and totation (by
manua 1ly-controlied alternating pressure) with pressure-relieving capabilities, as
well as provide an aid to a nurse or other care-giver, in the home, nursing home,
or other clinical setting, to assist a patient in shifting their body position, to
minimize possibility of bed sores, or other problems that can result fram lying or
sitting in one position for excessive periods of time.
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/K973624 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973624: Nurse's Aid Patient Rotation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973624
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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