510(k) K911780 ยท BZD Ventilator, Non-Continuous (Respirator)
INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
| Applicant | Ackrad Laboratories, Cranford NJ, US |
| Decision | Substantially Equivalent, Jun 24, 1991 |
| Received | Apr 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911780
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | CooperSurgical, Inc. INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715. Open, Classified |
BZD | None listed |
| Sep 18, 2026 | CooperSurgical, Inc. INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715. Open, Classified |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.