# K081264: Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002

- Pathway: 510(k) (Traditional)
- Applicant: Children'S Health First, Inc.
- Decided: Feb 13, 2009 after 284 days
- Product code: FMQ (Restraint, Protective)
- Device class: 1
- Regulation: 21 CFR 880.6760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K850496 (1985). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031096: Modification to Transport Incubator 185, International Biomedics, Inc. (2003) Summary page 1.
- K850496: Transport Incubator 185, Airborne Life Support Systems, Inc. (1985) Summary page 1.
- K001019: TI500 Globe-Trotter Transport System, Hill-Rom Air-Shields (2000). Our reading of the summary gave K000019, FDA’s number for Single Size Tendon Spacer (Medist International). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Model T1500 & Ti500 with restraint straps — Hill-Rom Airshield”. Summary page 3.
- K941106: Model TI500 Isolette Infant Incubator, Air-Shields, Inc. (1994) Summary page 1.

## Indications for use
Securing newborn infants of various sizes and weights within a Neonatal Transport Incubator.

Source page: https://510kreport.com/device/K081264
Methodology: https://510kreport.com/methodology