510(k) · Cleared
ClearedModel 720 Series Full/Semi Electric Bed 1120 Full Electric Bed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · FNL Bed, Ac-Powered Adjustable Hospital
Cleared on Jan 6, 1998 as substantially equivalent to K925534 (Ivacare Corp., 1993) after a 50-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jan 6, 1998
- Review
- 50 days
- Class
- Class II
- Product code
- FNL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925534 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK925534 Full/Semi Electric Home Care BedIvacare Corp. · 1993
- This deviceK974296 Model 720 Series Full/Semi Electric Bed 1120 Full Electric BedInvacare Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925534 | Full/Semi Electric Home Care Bed | Ivacare Corp. | 1993 | — |
| 0 (this device) | K974296 | Model 720 Series Full/Semi Electric Bed 1120 Full Electric Bed | Invacare Corp. | 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 FNL? 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 FNL device
- #1 K202964 iBed Wireless with iBed Mobilescore 2.4 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K925534 | Full/Semi Electric Home Care BedSummary page 1…720 Series Full/Semi Electric Bed and 1120 Full Electric Bed are substantially equivalent to Invacare Corporation’s 5110, 5210, 5310 and 5410 Series of Home Care Beds (K925534). Intended Use The intended use of the Model 720 Series Full/Semi Electric and 1120 Full Electric Beds is to pro… | 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 FNL devicesFNL Bed, Ac-Powered Adjustable Hospital: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FNL
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · FNL
Too few FNL 510(k)s in any year since 2007 to give a median.
Recalls per year · FNL
1in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FNL
2,748in 2025
MAUDE reports naming product code FNL, 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 | — | 2 | 133 |
| 2008 | 0 | — | 8 | 4,482 |
| 2009 | 0 | — | 16 | 7,460 |
| 2010 | 1 | — | 6 | 12,462 |
| 2011 | 0 | — | 7 | 12,599 |
| 2012 | 0 | — | 9 | 14,612 |
| 2013 | 0 | — | 4 | 13,473 |
| 2014 | 0 | — | 4 | 5,887 |
| 2015 | 0 | — | 1 | 3,036 |
| 2016 | 0 | — | 1 | 2,075 |
| 2017 | 0 | — | 0 | 1,047 |
| 2018 | 0 | — | 2 | 1,214 |
| 2019 | 0 | — | 1 | 1,113 |
| 2020 | 0 | — | 0 | 1,106 |
| 2021 | 1 | — | 0 | 1,377 |
| 2022 | 0 | — | 2 (1) | 1,118 |
| 2023 | 0 | — | 15 | 2,185 |
| 2024 | 0 | — | 1 | 2,327 |
| 2025 | 0 | — | 0 | 2,748 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
To provide added comfort during periods of bedrest by permitting the user to adjust the surface contour of the bed to various positions.
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/K974296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974296: Model 720 Series Full/Semi Electric Bed 1120 Full Electric Bed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974296
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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