# K993449: Bird V.I.P. Gold/Sterling

- Pathway: 510(k) (Special)
- Applicant: Bird Products Corp.
- Decided: Dec 20, 1999 after 69 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K902859 (1991). 5 ancestors in all.
134 later devices descend from it; 1 cites it directly.
41 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970839: Servo Ventilator 300A, Siemens Elema AB (1997) Summary page 1.
- K901885: Partner Volume Monitor, Bird Products Corp. (1990) Summary page 1.
- K915488: Pediatric Ventilator and Partner Volume Monitor, Bird Products Corp. (1992) Summary page 1.

## Cited in the summary but kept off the family tree
- K930474: Needle, Pneumoperitoneum, Spring Loaded, Ranfac, Corp. (1993). Our OCR of the scanned summary read K930474, FDA’s number for Needle, Pneumoperitoneum, Spring Loaded (Ranfac, Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Bird 8400Sti”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K013642: AVEA (2002), 133 descendants of its own
- K032451: Bird Tbird Vela Ventilator (2004), 114 descendants of its own
- K052554: Modification to: Ivent 201 Portable Ventilator (2005), 112 descendants of its own
- K053270: IVENT 201 (2006), 87 descendants of its own
- K061627: Modification to I Vent 201 (2006), 86 descendants of its own

## Recalls of this device
- Oct 20, 2006 · Not classified · Z-0480-2007: The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.
- Oct 20, 2006 · Not classified · Z-0481-2007: The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.

## Indications for use
The VIP Bird Gold and VIP Sterling are ventilators intended to treat respiratory failure or respiratory insufficiency, in neonatal, infant and pediatric patients. The ventilators are intended for institutional use only, and not for emergency medical transport or home use.

Source page: https://510kreport.com/device/K993449
Methodology: https://510kreport.com/methodology