510(k) · Cleared
ClearediBed Wireless with iBed Mobile
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 Jun 18, 2021 as substantially equivalent to K103536 (Stryker Corporation, 2010) after a 261-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Jun 18, 2021
- Review
- 261 days
- Class
- Class II
- Product code
- FNL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K925529 (1993). 5 ancestors in all, the oldest K922352 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK925529 Wander CareCare Electronics, Inc. · 1993
- 3 generations backK090138 Mobilecare Monitor, Model 2100Aframe Digital, Inc. · 2009
- 2 generations backK101109 VivatrakWireless Medcare, LLC · 2010
- 1 generation backK103536 Ibed Wireless with Ibed AwarenessStryker Corporation · 2010
- This deviceK202964 iBed Wireless with iBed MobileStryker Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925529 | Wander Care | Care Electronics, Inc. | 1993 | — |
| −3 | K090138 | Mobilecare Monitor, Model 2100 | Aframe Digital, Inc. | 2009 | — |
| −2 | K101109 | Vivatrak | Wireless Medcare, LLC | 2010 | — |
| −1 | K103536 | Ibed Wireless with Ibed Awareness | Stryker Corporation | 2010 | — |
| 0 (this device) | K202964 | iBed Wireless with iBed Mobile | Stryker Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K103536 | Ibed Wireless with Ibed AwarenessSummary page 4…de: FNL Class: Class II Review Panel: General Hospital III. PREDICATE DEVICE iBed™ Wireless with iBed™ Awareness, K103536 (Stryker Corporation) IV. DEVICE DESCRIPTION The Model 5212 iBed™ Wireless with iBed™ Mobile consists of iBed™ Wireless (WiFi m… | 2010 |
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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 10.5 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K103536.
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. 2021, 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 of the iBed™ Wireless with iBed™ Mobile accessory is to assist healthcare professionals in setting, adjusting, and monitoring specific bed parameters from a different location within the healthcare delivery organization’s campus. The iBed™ Wireless with iBed™ Mobile accessory is intended to be used only with Stryker Medical’s AC-powered adjustable hospital beds that have been verified and validated with the iBed™ Wireless software and is not intended to provide information on non-Stryker Medical beds. The iBed™ Wireless with iBed™ Mobile accessory is intended to only transfer bed status and parameter data and does not store this data.
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/K202964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K202964: iBed Wireless with iBed Mobile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K202964
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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