510(k) · Cleared
ClearedThe Advance Series From Hill-Rom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom, Inc. · FNL Bed, Ac-Powered Adjustable Hospital
Cleared on Oct 13, 1992 after a 147-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Oct 13, 1992
- Review
- 147 days
- Class
- Class II
- Product code
- FNL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK922352 The Advance Series From Hill-RomHill-Rom, Inc. · 1992
- Descendant · cites it directly · 3 of its ownK103536 Ibed Wireless with Ibed AwarenessStryker Corporation · 2010
- Descendant · cites it directly · 1 of its ownK962942 TotalcareHill-Rom, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 0 of its ownK202964 iBed Wireless with iBed MobileStryker Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK143414 Hill-Rom Wireless Connectivity ModuleHill-Rom · 2015
- Descendant · 2 generations on · 0 of its ownK122473 Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed…Hill-Rom · 2013 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K103536Ibed Wireless with Ibed AwarenessStryker Corporation · 2010 · cites it directly3descendants
- K962942TotalcareHill-Rom, Inc. · 1997 · cites it directly1descendant
- K202964iBed Wireless with iBed MobileStryker Corporation · 2021 · 2 generations on0descendants
- K143414Hill-Rom Wireless Connectivity ModuleHill-Rom · 2015 · 2 generations on0descendants
- K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2Hill-Rom · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922352 | The Advance Series From Hill-Rom | Hill-Rom, Inc. | 1992 | — |
| +1 | K103536 | Ibed Wireless with Ibed Awareness | Stryker Corporation | 2010 | — |
| +1 | K962942 | Totalcare | Hill-Rom, Inc. | 1997 | 1 |
| +2 | K202964 | iBed Wireless with iBed Mobile | Stryker Corporation | 2021 | — |
| +2 | K143414 | Hill-Rom Wireless Connectivity Module | Hill-Rom | 2015 | — |
| +2 | K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System… | Hill-Rom | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K103536 (Stryker Corporation, 2010) has gone furthest, with 3 descendants of its own.
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) | — |
https://510kreport.com/device/K922352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K922352: The Advance Series From Hill-Rom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K922352
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026