Harris-Lake, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Harris-Lake, Inc.” (first 1976, latest 1977), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 9 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 |
|---|---|---|---|
| KDP | Regulator, Vacuum | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
Review panels
- Anesthesiology (4)
- General Hospital (3)
Most recent Harris-Lake, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K761294 | RESPIRATORY BLOWER | BTI | 1977-01-03 | 13 |
| K761293 | RESPIRATORY HUMIDIFIER | BTT | 1977-01-03 | 13 |
| K761295 | RESP. AIR TEMP. CONTROL & HAZARD MON. | BZE | 1976-12-30 | 9 |
| K760333 | JAR, COLLECTOR FOR SUCTION SYSTEMS | GCX | 1976-10-27 | 90 |
| K760317 | REGULATORS, HIGH SUCTION | KDP | 1976-08-04 | 9 |
| K760316 | REGULATORS, LOW SUCTION | KDP | 1976-08-04 | 9 |
| K760314 | FLOWMETER, OXYGEN | CAX | 1976-08-04 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named Harris-Lake, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Harris-Lake, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Harris-Lake, Inc.” (first 1976, latest 1977), across 6 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 Harris-Lake, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Harris-Lake, Inc. is 9 days.
Which FDA product codes appear under Harris-Lake, Inc.?
The most frequent FDA product codes under this applicant name are KDP (Regulator, Vacuum, 2); BTI (Compressor, Air, Portable, 1); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 1).
Next steps
- See all 7 Harris-Lake, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDP, Harris-Lake, 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.