510(k) · Cleared
Recalled · Class II · 2021Affinity Bed Model 3600 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom, Inc. · KNC Table, Obstetric (And Accessories)
Cleared on Feb 24, 1993 after a 428-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 11 times.
- Decided
- Feb 24, 1993
- Review
- 428 days
- Class
- Class II
- Product code
- KNC
- Recalls
- 11
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 KNC? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2021 | Class II | Z-2156-2021 | Device Design | Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall. |
| Jul 15, 2016 | Class II | Z-2750-2016 | Nonconforming Material/Component | |
| Jun 26, 2014 | Class II | Z-2562-2014 | Nonconforming Material/Component | The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could lead to improper engagement of the foot section and this could result in injury to the user due to a fall. |
| Nov 16, 2009 | Not classified | Z-0548-2010 | Device Design | The brakes may not hold or lock. |
| Nov 21, 2007 | Not classified | Z-0581-2008 | Device Design | Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated. |
| Nov 21, 2007 | Not classified | Z-0583-2008 | Device Design | Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated. |
| Nov 21, 2007 | Not classified | Z-0582-2008 | Device Design | Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated. |
| Nov 21, 2007 | Not classified | Z-0584-2008 | Device Design | Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated. |
| Sep 6, 2007 | Not classified | Z-0617-2008 | Component design/selection | Brake failure: The brakes may not hold or lock properly. |
| Aug 18, 2006 | Not classified | Z-1503-06 | Other | The cable on the auxiliary outlet may become pinched, which may result in an electrical short with melting of the plastic transformer and the emission of smoke. |
| Apr 24, 2003 | Not classified | Z-0902-03 | Other | Possible electrical shock hazard, as the power cord grounding pin may break off or become detached. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KNC devicesKNC Table, Obstetric (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNC
FDA has decided no KNC device since 2007.
Median 510(k) review, days · KNC
Too few KNC 510(k)s in any year since 2007 to give a median.
Recalls per year · KNC
4in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNC
113in 2025
MAUDE reports naming product code KNC, 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 | — | 4 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 37 |
| 2019 | 0 | — | 0 | 60 |
| 2020 | 0 | — | 0 | 44 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 25 |
| 2023 | 0 | — | 0 | 45 |
| 2024 | 0 | — | 0 | 71 |
| 2025 | 0 | — | 0 | 113 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K915779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915779: Affinity Bed Model 3600 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915779
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026