ECG
7 FDA 510(k) clearances · Product code
48 daysmedian time to decision
87 days90th percentile
7clearances measured
FDA profile
- Official device name
- Sterilizer, Boiling Water
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6710
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1 · 1996: 1 · 1997: 1 · 1998: 1 · 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EAGLE DS (K895164) | American Sterilizer Co. | 1989-11-17 |
| CITOMAT AUTOCLAVES (K843234) | Lic-Orthion | 1984-10-25 |
| MAGNETIC RETENTION UNIT (K811237) | Universiti Malaya | 1981-06-16 |
| ENDODONTIC POST SYSTEMS (K810977) | Preat Corp. | 1981-05-13 |
| NEY EQUI-HINGE (K790290) | Deringer-Ney, Inc. | 1979-04-10 |
| BAR & RIDER, SCREWS, TUBES (K790078) | Eurodent, Inc. | 1979-02-27 |
| STEAM STERILIZER (K771266) | Amsco Hospital Products Co. | 1977-08-02 |
Track ECG automatically
Every clearance here is in the API, with alerts when new ones post.