Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spacelabs Healthcare, Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
469 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212317 | Eclipse MINI Model 98900 | Spacelabs Healthcare, Ltd. | 2022-11-07 | 469 | 1 |
| K211651 | Eclipse PRO | Spacelabs Healthcare, Ltd. | 2021-11-22 | 178 | 1 |
| K201921 | Spacelabs Lifescreen PRO Analyzer | Spacelabs Healthcare, Ltd. | 2021-03-26 | 259 | 0 |
| K152881 | SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM | Spacelabs Healthcare, Ltd. | 2016-04-01 | 184 | 1 |
| K141113 | SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (A | Spacelabs Healthcare, Ltd. | 2014-09-26 | 149 | 0 |
| K130207 | SPACELABS HEALTHCARE CARDIOEXPRESS | Spacelabs Healthcare, Ltd. | 2013-07-23 | 176 | 0 |
| K110001 | SPACELABS PATHFINDER SL HOLTER ANALYZER | Spacelabs Healthcare, Ltd. | 2011-06-14 | 162 | 1 |
| K101850 | SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION | Spacelabs Healthcare, Ltd. | 2011-03-02 | 244 | 1 |
| K103732 | SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONIT | Spacelabs Healthcare, Ltd. | 2011-02-04 | 44 | 1 |
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