Intl. Business Machines: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Intl. Business Machines” (first 1977, latest 1983), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 26 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 |
|---|---|---|---|
| GKT | Separator, Automated, Blood Cell, Diagnostic | 2 | 2 |
| LOS | 2 | 2 | |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 1 | 1 |
Review panels
Most recent Intl. Business Machines 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K831004 | AUTOMATED 8400 BLOOD CELL SEPARATOR | LKN | 1983-09-12 | 167 |
| K830163 | IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS | DSI | 1983-02-18 | 31 |
| K812355 | IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 | CAC | 1981-09-09 | 21 |
| K810989 | IBM 5880 ACQUISITION & ANALYSIS CART TEL | LOS | 1981-05-01 | 18 |
| K810988 | IBM 5885 DIGITAL ECG ACQUISITION CART | DPS | 1981-05-01 | 18 |
| K772353 | EKG ACQUISITION & ANALYSIS CART | LOS | 1978-01-06 | 14 |
| K771258 | BLOOD CELL SEPARATOR 2997 | GKT | 1977-09-06 | 56 |
| K760856 | BLOOD CELL PROCESSOR MODEL 2 IBM 2991 | GKT | 1977-01-10 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Intl. Business Machines.
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.
- Intl. Diagnostic Technology (29 510(k)s)
- Intl. Immunoassay Laboratories, Inc. (27 510(k)s)
- Intl. Medical, Inc. (17 510(k)s)
- Intl. Remote Imaging Systems (14 510(k)s)
- Intl. Medical Devices , Ltd. (12 510(k)s)
- Intl. Playtex, Inc. (10 510(k)s)
- Intl. Bioclinical, Inc. (6 510(k)s)
- Intl. Diagnostic, Inc. (6 510(k)s)
- Intl. Medical Consultants (6 510(k)s)
- Intl. Medical Equipment Corp. (6 510(k)s)
- Intl. Ophthalmic Industries Corp. (6 510(k)s)
- Intl. Trade Management Co. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intl. Business Machines?
FDA lists 8 510(k) clearances under the applicant name “Intl. Business Machines” (first 1977, latest 1983), across 6 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 Intl. Business Machines?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intl. Business Machines is 26 days.
Which FDA product codes appear under Intl. Business Machines?
The most frequent FDA product codes under this applicant name are GKT (Separator, Automated, Blood Cell, Diagnostic, 2); LOS (device, 2); CAC (Apparatus, Autotransfusion, 1).
Next steps
- See all 8 Intl. Business Machines clearances with predicates and recalls
- Run predicate analysis for product code GKT, Intl. Business Machines'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.