Hamilton Medical, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Hamilton Medical, Inc.” (first 1985, latest 2004), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 10 | 10 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 2 | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| GBX | Catheter, Irrigation | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Hamilton Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040574 | GALILEO GOLD | CBK | 2004-10-27 | 237 |
| K001686 | GALILEO VENTILATOR | CBK | 2000-06-23 | 36 |
| K982910 | HAMILTON MEDICAL GALILEOVENTILATOR | CBK | 1999-09-14 | 392 |
| K990293 | ALADDIN II MONITORING OXYGEN/AIR MONITOR | BZR | 1999-03-16 | 46 |
| K960359 | ALADDIN MONITORING OXYGEN/AIR MIXER | BZR | 1996-04-24 | 90 |
| K945740 | INFANT FLOW SYSTEM | BZO | 1995-03-23 | 120 |
| K901448 | VEOLAR VENTILATOR | CBK | 1991-12-20 | 632 |
| K900465 | MAX TRANSPORT VENTILATOR | CBK | 1990-06-18 | 138 |
| K894426 | LEONARDO INFORMATION SYSTEM | CBK | 1989-09-26 | 71 |
| K894316 | AMADEUS VENTILATOR | CBK | 1989-09-22 | 70 |
5 earlier clearances. See the full list in Caduvo.
Recalls
25 product recalls in 13 recall events; 10 initiated in the last five years. Most recent: 2023-07-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hamilton Medical AG (30 510(k)s)
- Hamilton Co. (16 510(k)s)
- Hamilton Thorne, Inc. (6 510(k)s)
- Hamilton Industries, Inc. (5 510(k)s)
- Hamilton Thorne Research (5 510(k)s)
- Hamilton Thorne Biosciences (2 510(k)s)
- Hamilton Kent (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hamilton Medical, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Hamilton Medical, Inc.” (first 1985, latest 2004), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hamilton Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hamilton Medical, Inc. is 90 days.
Which FDA product codes appear under Hamilton Medical, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 10); BZR (Mixer, Breathing Gases, Anesthesia Inhalation, 2); BZO (Set, Tubing And Support, Ventilator (W Harness), 1).
Next steps
- See all 15 Hamilton Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Hamilton Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.