FDA product code DSF: Recorder, Paper Chart
DSF is the FDA product code for recorder, paper chart. It is a Class I device, regulated under 21 CFR 870.2810 and reviewed by the Cardiovascular panel. FDA has cleared 87 510(k) submissions under DSF, from 55 different applicants. The average 510(k) review took 72 days (median 50). FDA has posted 1 recall for DSF devices.
Classification
| Field | Value |
|---|---|
| Device name | Recorder, Paper Chart |
| Device class | Class I |
| Regulation | 21 CFR 870.2810 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DSF clearance
Top DSF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Honeywell, Inc. | 6 | 1990-06-19 |
| Hewlett-Packard Co. | 5 | 1987-11-04 |
| Edentec Corp. | 4 | 1991-08-29 |
| Ge Medical Systems Information Technologies | 3 | 1991-01-11 |
| Physio-Control Corp. | 3 | 1988-06-09 |
50 more applicants have DSF clearances. See the full list in Caduvo.
Most recent DSF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K910871 | Edentec Corp. | EDENTEC DIGITAL CHARTER MODEL 3710 | 1991-08-29 | 181 |
| K912929 | Astro-Med, Inc. | DASH IV | 1991-08-13 | 39 |
| K905856 | Ge Medical Systems Information Technologies | MODEL 556 MONITOR | 1991-01-11 | 88 |
| K902586 | Gri Medical Products, Inc. | GRI LASERGRAPH(TM) ECG PAPER | 1990-06-22 | 10 |
| K902230 | Honeywell, Inc. | COLORADO COLOR IMAGING RECORDER | 1990-06-19 | 33 |
Recalls for DSF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-12-02.
Frequently asked questions
What is FDA product code DSF?
DSF is the FDA product code for recorder, paper chart. It is a Class I device, regulated under 21 CFR 870.2810 and reviewed by the Cardiovascular panel.
What device class is DSF?
Class I, regulation 21 CFR 870.2810. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DSF?
Across 87 cleared submissions the average was 72 days from receipt to decision (median 50).
Which companies have the most DSF clearances?
Honeywell, Inc. (6); Hewlett-Packard Co. (5); Edentec Corp. (4); Ge Medical Systems Information Technologies (3); Physio-Control Corp. (3).
Have DSF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-12-02.
Next steps
- Run an FDA pathway report with predicate devices for product code DSF
- Run a recall and safety report across every DSF manufacturer
- Watch product code DSF 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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