Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Outset Medical, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
235 daysmedian FDA review time
451 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. | 2026-01-26 | 118 | 0 |
| K232776 | Tablo® Hemodialysis System; TabloCart™ with Prefiltration Dr | Outset Medical, Inc. | 2024-05-03 | 235 | 1 |
| K233335 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023-12-05 | 67 | 3 |
| K223248 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023-06-21 | 243 | 0 |
| K211370 | Tablo Hemodialysis System | Outset Medical, Inc. | 2022-07-29 | 451 | 1 |
| K210782 | Tablo Cartridge | Outset Medical, Inc. | 2021-11-26 | 255 | 0 |
| K200741 | Tablo Hemodialysis System | Outset Medical, Inc. | 2020-03-31 | 8 | 0 |
| K190793 | Tablo Hemodialysis System, Tablo Cartridge | Outset Medical, Inc. | 2019-12-12 | 259 | 1 |
| K160881 | Tablo Console | Outset Medical, Inc. | 2016-11-15 | 230 | 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