FDA product code · Cardiovascular
DSHRecorder, Magnetic Tape, Medical
Product code DSH covers Recorder, Magnetic Tape, Medical, a Class II device regulated under 21 CFR 870.2800. FDA has cleared 195 devices in this code, 4 of them in the last 12 months. Median review time across the 195 most recent decisions is 83 days. openFDA lists no recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.2800
- Review panel
- Cardiovascular
- Clearances
- 195
What is happening in DSH right now?
DSH (Recorder, Magnetic Tape, Medical) has two findings, most consequential first. 1 first-time filer in the last 12 months, Smwmed, Inc (K252389). The code is crowded, scoring 73 of 100 — 118 companies hold a clearance here and 4 arrived in the last 12 months (DSH:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K252389 |
| Crowding | Context | DSH:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in DSH?
FDA has cleared 195 devices under product code DSH since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | |
| K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. | |
| K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. | |
| K243650 | Zio® monitor (DFG0001) | iRhythm Technologies, Inc. | |
| K243603 | AeviceMD | Aevice Health Pte. , Ltd. | |
| K242583 | AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. | |
| K232670 | HiCardi+ H100 | MEZOO Co., Ltd. | |
| K233906 | S-Patch (S-Patch ExL) | Wellysis Corp. | |
| K231104 | ABPMpro | Somnomedics GmbH | |
| K233110 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. |
How long does FDA review take for DSH?
The median FDA review time for DSH is 83 days, measured across the 195 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in DSH?
openFDA lists no recall records against product code DSH. That is the absence of a record, not a guarantee of safety.
Source: openFDA device/recall · retrieved
How many adverse events are reported for DSH?
MAUDE holds 426 adverse-event reports naming product code DSH, 207 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in DSH unusual?
3 months sit above DSH's own expected range: 1 August 2025, 1 December 2025, 1 February 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 15 | 2–16 | Within expected (2–16) | |
| 9 | 2–17 | Within expected (2–17) | |
| 12 | 2–18 | Within expected (2–18) | |
| 17 | 2–20 | Within expected (2–20) | |
| 10 | 4–20 | Within expected (4–20) | |
| 14 | 5–19 | Within expected (5–19) | |
| 13 | 8–31 | Within expected (8–31) | |
| 29 | 6–21 | Above expected (6–21) | |
| 21 | 7–31 | Within expected (7–31) | |
| 14 | 8–31 | Within expected (8–31) | |
| 23 | 6–26 | Within expected (6–26) | |
| 33 | 9–32 | Above expected (9–32) | |
| 27 | 11–44 | Within expected (11–44) | |
| 39 | 9–37 | Above expected (9–37) | |
| 28 | 11–50 | Within expected (11–50) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in DSH.
Who has entered DSH in the last year?
One company filed in DSH for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Smwmed, Inc. | K252389 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in DSH?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in DSH?
Across the 195 most recent decisions, these applicants filed most often in DSH.
| Applicant | Recent clearances |
|---|---|
| Del Mar Avionics | 15 |
| Bardy Diagnostics, Inc. | 7 |
| Oxford Medilog, Inc. | 6 |
| iRhythm Technologies, Inc. | 6 |
| Cardiocomm Solutions, Inc. | 4 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch DSH
Get an email the morning anything changes in DSH — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.