510(k) · Cleared
ClearedIbed Wireless with Ibed Awareness
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · FNL Bed, Ac-Powered Adjustable Hospital
Cleared on Dec 16, 2010 as substantially equivalent to K922352 (Hill-Rom, Inc., 1992) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 1993. 3 later devices descend from it.
- Decided
- Dec 16, 2010
- Review
- 15 days
- Class
- Class II
- Product code
- FNL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925529 (1993). 4 ancestors in all, the oldest K922352 (1992). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK925529 Wander CareCare Electronics, Inc. · 1993
- 2 generations backK090138 Mobilecare Monitor, Model 2100Aframe Digital, Inc. · 2009
- 1 generation backK101109 VivatrakWireless Medcare, LLC · 2010
- This deviceK103536 Ibed Wireless with Ibed AwarenessStryker Corporation · 2010
- Descendant · cites it directly · 0 of its ownK202964 iBed Wireless with iBed MobileStryker Corporation · 2021
- Descendant · cites it directly · 0 of its ownK143414 Hill-Rom Wireless Connectivity ModuleHill-Rom · 2015
- Descendant · cites it directly · 0 of its ownK122473 Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed…Hill-Rom · 2013 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K202964iBed Wireless with iBed MobileStryker Corporation · 2021 · cites it directly0descendants
- K143414Hill-Rom Wireless Connectivity ModuleHill-Rom · 2015 · cites it directly0descendants
- K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2Hill-Rom · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925529 | Wander Care | Care Electronics, Inc. | 1993 | — |
| −2 | K090138 | Mobilecare Monitor, Model 2100 | Aframe Digital, Inc. | 2009 | — |
| −1 | K101109 | Vivatrak | Wireless Medcare, LLC | 2010 | — |
| 0 (this device) | K103536 | Ibed Wireless with Ibed Awareness | Stryker Corporation | 2010 | — |
| +1 | K202964 | iBed Wireless with iBed Mobile | Stryker Corporation | 2021 | — |
| +1 | K143414 | Hill-Rom Wireless Connectivity Module | Hill-Rom | 2015 | — |
| +1 | K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System… | Hill-Rom | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K922352 | The Advance Series From Hill-RomSummary page 1…FNL Classification Panel: General Hospital Classification: Class 11 Predicate Devices: Advance Series from Hill-Rom, Hill-Rom (K(922352) VivaTRAKTh, Wireless MedCARE, LLC (KiOI 109) Device Description The iBedTh Awareness is used to monitor hospital bed status and… | 1992 |
| * | K101109 | Vivatrak | 2010 |
What descends from it? (3)
3 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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K202964 (Stryker Corporation, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K922352.
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. 2010, this device’s year, is highlighted.
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?
The intended use for the iBedTm Wireless (with iBedTh Awareness) is to assist clinical staff to monitor bed parameters on specific Stryker beds. The desired bed parameters will be set by clinicians at the bedside. The iBedTM Wireless software is intended to be used only with specifically enabled Stryker beds that have been verified and validated with the iBed1 ~" Wireless software, and is not intended to provide bed status information for non-Stryker…
Read the full statement (159 words)
The intended use for the iBedTm Wireless (with iBedTh Awareness) is to assist clinical staff to monitor bed parameters on specific Stryker beds. The desired bed parameters will be set by clinicians at the bedside. The iBedTM Wireless software is intended to be used only with specifically enabled Stryker beds that have been verified and validated with the iBed1 ~" Wireless software, and is not intended to provide bed status information for non-Stryker beds. The iBedTm Wireless software is not intended to communicate any patient status information, nor to permanently store any type of data. The iBedTm Wireless with iBedTh Awareness System is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The iBed"" Wireless with iiBedTh Awareness System is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103536 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103536: Ibed Wireless with Ibed Awareness.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103536
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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