Adler Instrument Co.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Adler Instrument Co.” (first 1983, latest 1991), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| GAZ | Tubing, Noninvasive | 2 | 2 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 2 | 2 |
| HQO | Unit, Cautery, Thermal, Ac-Powered | 1 | 1 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Adler Instrument Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910171 | MAXI-FLOW SUCTION SET W/Y CONNECTOR | GAZ | 1991-02-01 | 17 |
| K910170 | MAXI-FLOW SUCTION SET 12 FT. | GAZ | 1991-02-01 | 17 |
| K903209 | MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER | HES | 1990-12-21 | 154 |
| K903208 | MAXI-FLOW INSUFFLATOR TUBING SET | HES | 1990-12-17 | 150 |
| K900913 | ADLER DISPOSABLE BIPOLAR CORD | HQO | 1990-04-04 | 36 |
| K841723 | ADLER CUSTOM PROCEDURE PACKS | — | 1984-08-01 | 98 |
| K833264 | ADLER STEAM INDICATOR-GAS INDICATOR | JOJ | 1983-11-03 | 44 |
| K831068 | CONTAINER SYSTEM | — | 1983-05-09 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Adler Instrument 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.
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.
- Adler Industries, Inc. (1 510(k)s)
- Adler Micromed, Inc. (1 510(k)s)
- Adler Ortho S.P.A (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Adler Instrument Co.?
FDA lists 8 510(k) clearances under the applicant name “Adler Instrument Co.” (first 1983, latest 1991), across 5 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 Adler Instrument Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Adler Instrument Co. is 40 days.
Which FDA product codes appear under Adler Instrument Co.?
The most frequent FDA product codes under this applicant name are GAZ (Tubing, Noninvasive, 2); HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories), 2); HQO (Unit, Cautery, Thermal, Ac-Powered, 1).
Next steps
- See all 8 Adler Instrument Co. clearances with predicates and recalls
- Run predicate analysis for product code GAZ, Adler Instrument 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.