Fraser Harlake, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Fraser Harlake, Inc.” (first 1981, latest 1984), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| CBN | Apparatus, Gas-Scavenging | 2 | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 | 1 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 1 | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
Review panels
Most recent Fraser Harlake, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841903 | FRASER HARLAKE EMERG. CARE SUCTION SYS | BTA | 1984-06-14 | 38 |
| K833799 | SPHYGOMANO METER | DXN | 1984-05-14 | 195 |
| K841496 | FRASER HARLAKE HOPE III RESUSCITATOR | BTM | 1984-04-24 | 14 |
| K833692 | FRASER HARLAKE DENTAL ANTI-POLUTION SYS | CBN | 1983-11-29 | 42 |
| K833151 | BOYLE SYSTEM ANESTHESIA GAS MACHINE | BSZ | 1983-11-14 | 60 |
| K831427 | CYPRANE TEC 4 CONTINUOUS FLOW VAPOR. | CAD | 1983-07-07 | 65 |
| K822040 | POWERED EMERGENCY VENTILATOR | CBK | 1982-08-19 | 38 |
| K821744 | FRASER HARLAKE NITRONOX SCAVENGER | CBN | 1982-06-25 | 11 |
| K802943 | POSITIVE END EXPIRATORY PRESSURE VALVE | BYE | 1981-01-15 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Fraser Harlake, Inc..
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.
- Fraser Sweatman, Inc. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fraser Harlake, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Fraser Harlake, Inc.” (first 1981, latest 1984), across 8 product codes in 3 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 Fraser Harlake, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fraser Harlake, Inc. is 42 days.
Which FDA product codes appear under Fraser Harlake, Inc.?
The most frequent FDA product codes under this applicant name are CBN (Apparatus, Gas-Scavenging, 2); BSZ (Gas-Machine, Anesthesia, 1); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Next steps
- See all 9 Fraser Harlake, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBN, Fraser Harlake, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.