Spacelabs Healthcare: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Spacelabs Healthcare” (first 2011, latest 2022), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 162 days. Since 2017 the median was 259 days, against 178 days for all cleared 510(k)s in the same product codes. 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 | 4 | 130 |
| 2013 | 3 | 176 |
| 2014 | 2 | 138 |
| 2015 | 1 | 268 |
| 2016 | 1 | 184 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 218 |
| 2022 | 1 | 469 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spacelabs Healthcare took a median 259 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 178 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 4 | 4 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 4 | 4 |
| CBK | Ventilator, Continuous, Facility Use | 3 | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 2 | 2 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
Review panels
- Cardiovascular (14)
- Anesthesiology (6)
Most recent Spacelabs Healthcare 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212317 | Eclipse MINI Model 98900 | MWJ | 2022-11-07 | 469 |
| K211651 | Eclipse PRO | MWJ | 2021-11-22 | 178 |
| K201921 | Spacelabs Lifescreen PRO Analyzer | DQK | 2021-03-26 | 259 |
| K152881 | SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM | DQK | 2016-04-01 | 184 |
| K150329 | elance Vital Signs Monitor, Central Monitor Software | MHX | 2015-11-05 | 268 |
| K141113 | SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE | DXN | 2014-09-26 | 149 |
| K141156 | SPACELABS HEALTHCARE TELEMETRY RECEIVER | MHX | 2014-09-09 | 127 |
| K130207 | SPACELABS HEALTHCARE CARDIOEXPRESS | DPS | 2013-07-23 | 176 |
| K122146 | XHIBIT CENTRAL STATION, MODEL 96102 | MHX | 2013-04-22 | 277 |
| K130112 | CAPNO MODULE, 92517 | CCK | 2013-03-21 | 64 |
10 earlier clearances. See the full list in Caduvo.
Recalls
61 product recalls in 56 recall events; 13 initiated in the last five years. Most recent: 2026-06-04.
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.
- Spacelabs, Inc. (46 510(k)s)
- Spacelabs Medical, Inc. (35 510(k)s)
- Spacelabs Burdick, Inc. (1 510(k)s)
- Spacelabs Healthcare Medical Equipment (Suzhou) CO (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spacelabs Healthcare?
FDA lists 20 510(k) clearances under the applicant name “Spacelabs Healthcare” (first 2011, latest 2022), across 9 product codes in 2 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 Spacelabs Healthcare?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spacelabs Healthcare is 162 days. Since 2017: 259 days, versus 178 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Spacelabs Healthcare?
The most frequent FDA product codes under this applicant name are DQK (Computer, Diagnostic, Programmable, 4); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 4); CBK (Ventilator, Continuous, Facility Use, 3).
Next steps
- See all 20 Spacelabs Healthcare clearances with predicates and recalls
- Run predicate analysis for product code DQK, Spacelabs Healthcare'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.