# K915779: Affinity Bed Model 3600 Series

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: Feb 24, 1993 after 428 days
- Product code: KNC (Table, Obstetric (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4900
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- May 28, 2021 · Class II · Z-2156-2021: 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 
- Jul 15, 2016 · Class II · Z-2750-2016: 
- Jun 26, 2014 · Class II · Z-2562-2014: 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
- Nov 16, 2009 · Not classified · Z-0548-2010: The brakes may not hold or lock.
- Nov 21, 2007 · Not classified · Z-0581-2008: 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: 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: 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: 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: Brake failure: The brakes may not hold or lock properly.
- Aug 18, 2006 · Not classified · Z-1503-06: 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: Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.

Source page: https://510kreport.com/device/K915779
Methodology: https://510kreport.com/methodology