Spacelabs, Inc.: FDA filings under this applicant name
FDA lists 46 510(k) clearances under the applicant name “Spacelabs, Inc.” (first 1976, latest 1996), across 21 product codes in 4 review panels. Median 510(k) review time under this name: 78 days. 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 | 0 | — |
| 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 | 11 | 11 |
| DQA | Oximeter | 4 | 4 |
| DPS | Electrocardiograph | 3 | 3 |
| DSH | Recorder, Magnetic Tape, Medical | 3 | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 2 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 2 | 2 |
Plus 11 more product codes.
Review panels
- Cardiovascular (31)
- Anesthesiology (9)
- General Hospital (3)
- Neurology (1)
Most recent Spacelabs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954962 | SPACELABS MEDICAL MULTIGAS ANALYZER | CBR | 1996-05-31 | 214 |
| K951605 | SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM | DSH | 1995-07-14 | 98 |
| K950779 | HEART RATE VARIABILITY SOFTWARE OPTION | DPS | 1995-04-25 | 63 |
| K941165 | COMET CAPNOGRAPH MODULE | CCK | 1994-10-06 | 209 |
| K923788 | SPACE LABS MODEL 90560 | LOS | 1993-12-06 | 496 |
| K912742 | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE | FLL | 1992-04-20 | 304 |
| K913038 | SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION | DSH | 1991-10-04 | 87 |
| K905065 | DEFIBRILLATOR LEAD ADAPTER | LDD | 1991-04-12 | 156 |
| K910029 | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION | DXK | 1991-01-31 | 28 |
| K896903 | FIRST MEDIC MODEL 510 | LDD | 1990-12-27 | 384 |
36 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Spacelabs, Inc..
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 Medical, Inc. (35 510(k)s)
- Spacelabs Healthcare (20 510(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, Inc.?
FDA lists 46 510(k) clearances under the applicant name “Spacelabs, Inc.” (first 1976, latest 1996), across 21 product codes in 4 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spacelabs, Inc. is 78 days.
Which FDA product codes appear under Spacelabs, Inc.?
The most frequent FDA product codes under this applicant name are DSI (Detector And Alarm, Arrhythmia, 11); DQA (Oximeter, 4); DPS (Electrocardiograph, 3).
Next steps
- See all 46 Spacelabs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Spacelabs, Inc.'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.