The London Co.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “The London Co.” (first 1976, latest 1980), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 | 2 |
| GHS | Assay, Carboxyhemoglobin | 1 | 1 |
| JFP | Electrode, Ion Specific, Calcium | 1 | 1 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 | 1 |
| JKS | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide | 1 | 1 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Anesthesiology (1)
- Hematology (1)
- Clinical Toxicology (1)
Most recent The London Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802846 | TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. | KLK | 1980-12-17 | 35 |
| K801848 | ICA1 IONIZED CALCIUM ANALYZER | JFP | 1980-10-31 | 88 |
| K800224 | RADIOMETER ACID BASE LABORATORY-ABL-3 | CHL | 1980-02-22 | 17 |
| K780652 | HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 | JKS | 1978-07-27 | 101 |
| K771444 | QUALICHECK TM | JJS | 1977-08-16 | 15 |
| K771263 | RADIOMHTER OSM-2 HEMOXIMETER | GHS | 1977-08-03 | 23 |
| K760229 | ACID BASE SYSTEM, RADIOMETER AUTOMATED | CHL | 1976-08-26 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named The London Co..
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 The London Co.?
FDA lists 7 510(k) clearances under the applicant name “The London Co.” (first 1976, latest 1980), across 6 product codes in 4 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 The London Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The London Co. is 35 days.
Which FDA product codes appear under The London Co.?
The most frequent FDA product codes under this applicant name are CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 2); GHS (Assay, Carboxyhemoglobin, 1); JFP (Electrode, Ion Specific, Calcium, 1).
Next steps
- See all 7 The London Co. clearances with predicates and recalls
- Run predicate analysis for product code CHL, The London Co.'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.