FDA product code DSB: Plethysmograph, Impedance
DSB is the FDA product code for plethysmograph, impedance. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Cardiovascular panel. FDA has cleared 115 510(k) submissions under DSB, 7 in the last five years, from 71 different applicants. The average 510(k) review took 188 days (median 132); 226 days on average over the last three years. FDA has posted 2 recalls for DSB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Plethysmograph, Impedance |
| Device class | Class II |
| Regulation | 21 CFR 870.2770 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DSB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 93 |
| 2018 | 1 | 215 |
| 2019 | 1 | 371 |
| 2020 | 2 | 270 |
| 2021 | 1 | 145 |
| 2022 | 1 | 431 |
| 2023 | 2 | 169 |
| 2025 | 3 | 250 |
| 2026 | 1 | 203 |
Compare with all 510(k) review times · Search every DSB clearance
Top DSB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardiodynamics International Corp. | 11 | 2009-05-28 |
| ImpediMed Limited | 5 | 2026-08-17 |
| Bomed Medical Mfr., Ltd. | 4 | 1986-04-14 |
| Vasocom, Inc. | 3 | 2014-02-12 |
| Noninvasive Medical Technologies, Inc. | 3 | 2014-01-22 |
66 more applicants have DSB clearances. See the full list in Caduvo.
Most recent DSB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260224 | ImpediMed Limited | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) | 2026-08-17 | 203 |
| K250634 | Fresenius Medical Care Renal Therapies Group, LLC | BCM2-Body Composition Monitor | 2025-11-24 | 266 |
| K243727 | Mode Sensors AS | Re:Balans | 2025-10-16 | 317 |
| K250922 | Cardioset Medical , Ltd. | Edema Guard Monitor (EGM) CardioSet-001 | 2025-09-09 | 166 |
| K232089 | ImpediMed Limited | SOZO Pro | 2023-10-17 | 96 |
Recalls for DSB devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-09-02.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code DSB?
DSB is the FDA product code for plethysmograph, impedance. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Cardiovascular panel.
What device class is DSB?
Class II, regulation 21 CFR 870.2770. Typical premarket route: 510(k).
How long does a 510(k) take for product code DSB?
Across 115 cleared submissions the average was 188 days from receipt to decision (median 132).
Which companies have the most DSB clearances?
Cardiodynamics International Corp. (11); ImpediMed Limited (5); Bomed Medical Mfr., Ltd. (4); Vasocom, Inc. (3); Noninvasive Medical Technologies, Inc. (3).
Have DSB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-09-02.
Next steps
- Run an FDA pathway report with predicate devices for product code DSB
- Run a recall and safety report across every DSB manufacturer
- Watch product code DSB 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times