# Sterile Design, Inc.

- Location (FDA's records): Oldsmar, FL
- FDA decisions: 10 (1979–1994): 10 510(k) clearances
- Product codes: FRG (1), JOD (1), FPA (1), FMC (1), DQX (1), DRS (1), DWE (1), LRO (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- D.I.R.R.a. S.R.L.: 1 (https://510kreport.com/company/dirra)
- Terumo Cardiovascular Systems Corp.: 1 (https://510kreport.com/company/terumo-cardiovascular-systems)

## Its most-cited devices
- K841959: Cardio Metric Custom Perfusion Tubing (1984), cited by 1
- K934688: Sterile Design (1994), cited by 1

## Recent decisions
- K934688: Sterile Design (Mar 16, 1994)
- K841960: Cardio Metrics Invasive Pressure Monit (Nov 8, 1985)
- K842356: Custom Sterile Procedure Kits (Mar 21, 1985)
- K841959: Cardio Metric Custom Perfusion Tubing (Oct 19, 1984)
- K841958: Cardio Metrics Cardiotomy Reservoir (Oct 15, 1984)
- K842351: Sterile Design-Custom Sterile IV Kit (Oct 15, 1984)
- K834239: Sdi C-Flex Sterile Light Handle (Apr 25, 1984)
- K834237: Graduated Guide Wire Bowl 8 (Feb 4, 1984)

Source page: https://510kreport.com/company/sterile-design