FDA product code ECG: Sterilizer, Boiling Water
ECG is the FDA product code for sterilizer, boiling water. It is a Class I device, regulated under 21 CFR 872.6710 and reviewed by the Dental panel. FDA has cleared 7 510(k) submissions under ECG, from 7 different applicants. The average 510(k) review took 52 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Sterilizer, Boiling Water |
| Device class | Class I |
| Regulation | 21 CFR 872.6710 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every ECG clearance
Top ECG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Sterilizer Co. | 1 | 1989-11-17 |
| Lic-Orthion | 1 | 1984-10-25 |
| Universiti Malaya | 1 | 1981-06-16 |
| Preat Corp. | 1 | 1981-05-13 |
| Deringer-Ney, Inc. | 1 | 1979-04-10 |
2 more applicants have ECG clearances. See the full list in Caduvo.
Most recent ECG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K895164 | American Sterilizer Co. | EAGLE DS | 1989-11-17 | 87 |
| K843234 | Lic-Orthion | CITOMAT AUTOCLAVES | 1984-10-25 | 69 |
| K811237 | Universiti Malaya | MAGNETIC RETENTION UNIT | 1981-06-16 | 43 |
| K810977 | Preat Corp. | ENDODONTIC POST SYSTEMS | 1981-05-13 | 33 |
| K790290 | Deringer-Ney, Inc. | NEY EQUI-HINGE | 1979-04-10 | 61 |
Recalls for ECG devices
openFDA lists no recalls for product code ECG.
Frequently asked questions
What is FDA product code ECG?
ECG is the FDA product code for sterilizer, boiling water. It is a Class I device, regulated under 21 CFR 872.6710 and reviewed by the Dental panel.
What device class is ECG?
Class I, regulation 21 CFR 872.6710. Typical premarket route: 510(k).
How long does a 510(k) take for product code ECG?
Across 7 cleared submissions the average was 52 days from receipt to decision (median 48).
Which companies have the most ECG clearances?
American Sterilizer Co. (1); Lic-Orthion (1); Universiti Malaya (1); Preat Corp. (1); Deringer-Ney, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ECG
- Run a recall and safety report across every ECG manufacturer
- Watch product code ECG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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