Spacelabs Medical, Inc.: FDA clearances and approvals
Spacelabs Medical, Inc. has 35 FDA 510(k) clearances (first 1993, latest 2012), across 12 product codes in 4 review panels. Median 510(k) review time: 151 days. openFDA lists 2 product recalls by a recalling firm named Spacelabs Medical, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 29 |
| 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 13 | 13 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 7 | 7 |
| BSZ | Gas-Machine, Anesthesia | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 2 | 2 |
| DXJ | Display, Cathode-Ray Tube, Medical | 2 | 2 |
| MSX | System, Network And Communication, Physiological Monitors | 2 | 2 |
| OLW | Index-Generating Electroencephalograph Software | 2 | 2 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (27)
- Anesthesiology (4)
- Neurology (3)
- Obstetrics and Gynecology (1)
Most recent Spacelabs Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120616 | SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 | MHX | 2012-03-29 | 29 |
| K112962 | SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) | MHX | 2011-11-02 | 28 |
| K102422 | SPACELABS MEDICAL PATIENT MONITORS | MHX | 2010-12-07 | 104 |
| K093501 | ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION | MHX | 2009-11-24 | 12 |
| K082045 | MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 | MHX | 2008-08-01 | 14 |
| K063490 | SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 | DQK | 2007-03-15 | 118 |
| K062095 | MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 | MHX | 2006-09-29 | 67 |
| K062278 | SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 | MSX | 2006-09-19 | 43 |
| K060900 | SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 | OLW | 2006-06-23 | 81 |
| K053599 | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES | CBR | 2006-04-19 | 117 |
25 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-05-07.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Spacelabs Medical, Inc. have?
Spacelabs Medical, Inc. has 35 FDA 510(k) clearances (first 1993, latest 2012), across 12 product codes in 4 review panels.
How long does FDA take to clear Spacelabs Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Spacelabs Medical, Inc.'s cleared 510(k)s is 151 days.
What devices does Spacelabs Medical, Inc. make?
Its most frequent FDA product codes are DSI (Detector And Alarm, Arrhythmia, 13); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 7); BSZ (Gas-Machine, Anesthesia, 2).
Has Spacelabs Medical, Inc. had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches Spacelabs Medical, Inc; the most recent began 2004-05-07. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 35 Spacelabs Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Spacelabs Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.