# Gibeck, Inc.

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 15 (1990–1997): 15 510(k) clearances
- Product codes: BYD (7), CAH (3), DWJ (2), CBL (1), CCK (1), IYT (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 6 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Flexicare Medical Limited.: 2 (https://510kreport.com/company/flexicare-medical)
- Teleflex Medical Sdn. Bhd.: 2 (https://510kreport.com/company/teleflex-medical-sdn-bhd)
- Hsiner Co., Ltd.: 1 (https://510kreport.com/company/hsiner)
- Engineered Medical Systems: 1 (https://510kreport.com/company/engineered-medical-systems)

## Its most-cited devices
- K964382: Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402) (1997), cited by 3
- K952084: Humid-Vent Filter Pedi (1995), cited by 1
- K965016: Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212) (1997), cited by 1
- K952845: Humid-Vent Trach-Vent (1995), cited by 1

## Recent decisions
- K965016: Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212) (Dec 2, 1997)
- K964377: Thermal Regulation System                                       Blanket (Apr 23, 1997)
- K964382: Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402) (Apr 15, 1997)
- K960511: Gibeck Warmbag Reusable Convective Warming Blanket (Jan 13, 1997)
- K954828: Iso-Gard Hepa Filter-Hme, Iso-Ard Hepa Filter-Hme W/Port (May 2, 1996)
- K953544: Humid-Vent 2 Light/Humid-Vent 2 Port Light (Aug 25, 1995)
- K953491: Humid-Vent 1 Port/Humid-Vent 1 Port Angle (Aug 25, 1995)
- K952845: Humid-Vent Trach-Vent (Jul 25, 1995)

Source page: https://510kreport.com/company/gibeck