Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Business Machines — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
167 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831004 | AUTOMATED 8400 BLOOD CELL SEPARATOR | Intl. Business Machines | 1983-09-12 | 167 | 0 |
| K830163 | IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS | Intl. Business Machines | 1983-02-18 | 31 | 0 |
| K812355 | IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 | Intl. Business Machines | 1981-09-09 | 21 | 0 |
| K810988 | IBM 5885 DIGITAL ECG ACQUISITION CART | Intl. Business Machines | 1981-05-01 | 18 | 0 |
| K810989 | IBM 5880 ACQUISITION & ANALYSIS CART TEL | Intl. Business Machines | 1981-05-01 | 18 | 0 |
| K772353 | EKG ACQUISITION & ANALYSIS CART | Intl. Business Machines | 1978-01-06 | 14 | 0 |
| K771258 | BLOOD CELL SEPARATOR 2997 | Intl. Business Machines | 1977-09-06 | 56 | 0 |
| K760856 | BLOOD CELL PROCESSOR MODEL 2 IBM 2991 | Intl. Business Machines | 1977-01-10 | 87 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda