FDA product code DSJ: Alarm, Blood-Pressure
DSJ is the FDA product code for alarm, blood-pressure. It is a Class II device, regulated under 21 CFR 870.1100 and reviewed by the Cardiovascular panel. FDA has cleared 6 510(k) submissions under DSJ, from 5 different applicants. The average 510(k) review took 127 days (median 95). FDA has posted 4 recalls for DSJ devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Alarm, Blood-Pressure |
| Device class | Class II |
| Regulation | 21 CFR 870.1100 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DSJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 98 |
| 2019 | 1 | 230 |
Compare with all 510(k) review times · Search every DSJ clearance
Top DSJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Philips Medical Systems | 2 | 2017-03-31 |
| Philips Medizin Systeme Boeblingen GmbH | 1 | 2019-10-27 |
| Phillips Medical Systems | 1 | 2015-09-29 |
| 3M Health Care, Sarns | 1 | 1996-06-04 |
| Keller Medical Specialties Products, Inc. | 1 | 1991-04-01 |
Most recent DSJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190624 | Philips Medizin Systeme Boeblingen GmbH | EarlyVue VS30 | 2019-10-27 | 230 |
| K163649 | Philips Medical Systems | SureSigns VS3; SureSigns VS4 | 2017-03-31 | 98 |
| K151761 | Phillips Medical Systems | SureSigns VS3, SureSigns VS4 | 2015-09-29 | 92 |
| K133961 | Philips Medical Systems | SURESIGNS VS3, SURESIGNS VS4 | 2014-06-26 | 184 |
| K960916 | 3M Health Care, Sarns | SAMS 8000 CARDIOPLEGIA MONITOR | 1996-06-04 | 90 |
Recalls for DSJ devices
4 product recalls in 2 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2023-08-31.
| Year | Recalls |
|---|---|
| 2023 | 4 |
Frequently asked questions
What is FDA product code DSJ?
DSJ is the FDA product code for alarm, blood-pressure. It is a Class II device, regulated under 21 CFR 870.1100 and reviewed by the Cardiovascular panel.
What device class is DSJ?
Class II, regulation 21 CFR 870.1100. Typical premarket route: 510(k).
How long does a 510(k) take for product code DSJ?
Across 6 cleared submissions the average was 127 days from receipt to decision (median 95).
Which companies have the most DSJ clearances?
Philips Medical Systems (2); Philips Medizin Systeme Boeblingen GmbH (1); Phillips Medical Systems (1); 3M Health Care, Sarns (1); Keller Medical Specialties Products, Inc. (1).
Have DSJ devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2023-08-31.
Next steps
- Run an FDA pathway report with predicate devices for product code DSJ
- Run a recall and safety report across every DSJ manufacturer
- Watch product code DSJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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