FDA product code · Cardiovascular
DQAOximeter
Product code DQA covers Oximeter, a Class II device regulated under 21 CFR 870.2700. FDA has cleared 726 devices in this code, 14 of them in the last 12 months. Median review time across the 726 most recent decisions is 125 days. openFDA lists 128 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.2700
- Review panel
- Cardiovascular
- Clearances
- 726
What is happening in DQA right now?
DQA (Oximeter) has four findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1142-2026, Z-1143-2026, Z-1152-2026, Z-1153-2026). 3 first-time filers in the last 12 months, including Philips Medizin Systeme and Shenzhen Best Electronics Co., Ltd (K253887, K253109, K251751). Clearances are running 35% slower — a median 169 days over the last 12 months against 125 days all-time (elapsed calendar days, not FDA review days) (DQA:review_time:12m). The code is crowded, scoring 94 of 100 — 261 companies hold a clearance here and 14 arrived in the last 12 months (DQA:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1142-2026, Z-1143-2026, Z-1152-2026, Z-1153-2026 |
| New entrant | Worth knowing | K253887, K253109, K251751 |
| Review time | Context | DQA:review_time:12m |
| Crowding | Context | DQA: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 DQA?
FDA has cleared 726 devices under product code DQA since the 510(k) programme began in 1976, 14 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | Philips Medizin Systeme Böblingen GmbH | |
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) | Shenzhen Imdk Medical Technology Co., Ltd. | |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) | Philips Medizin Systeme | |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. | |
| K252448 | AViTA Pulse Oximeter (SP61) | Avita Corporation | |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | Shenzhen Best Electronics Co., Ltd. | |
| K251751 | Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. | |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) | Unimed Medical Supplies, Inc. | |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) | Unimed Medical Supplies, Inc. |
How long does FDA review take for DQA?
The median FDA review time for DQA is 125 days, measured across the 726 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 DQA?
openFDA lists 128 recall records against product code DQA. A recall record covers one firm's corrective action and may span many device lots.
Z-1142-2026Open, ClassifiedEdan Diagnostics
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-1143-2026Open, ClassifiedEdan Diagnostics
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-1152-2026Open, ClassifiedEdan Diagnostics
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-1153-2026Open, ClassifiedEdan Diagnostics
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-2151-2025Open, ClassifiedCovidien
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
Showing the 5 most recently initiated of 128. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for DQA?
MAUDE holds 1,496 adverse-event reports naming product code DQA, 433 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 DQA unusual?
One month sits above DQA's own expected range: 1 December 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 28 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 46 | Insufficient history | No expected range — too little history | |
| 39 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 37 | Insufficient history | No expected range — too little history | |
| 39 | Insufficient history | No expected range — too little history | |
| 34 | Insufficient history | No expected range — too little history | |
| 61 | Insufficient history | No expected range — too little history | |
| 88 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 36 | Insufficient history | No expected range — too little history | |
| 76 | Insufficient history | No expected range — too little history | |
| 27 | Insufficient history | No expected range — too little history | |
| 30 | Insufficient history | No expected range — too little history | |
| 44 | Insufficient history | No expected range — too little history | |
| 30 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 74 | Insufficient history | No expected range — too little history | |
| 29 | Insufficient history | No expected range — too little history | |
| 23 | 0–82 | Within expected (0–82) | |
| 22 | 0–68 | Within expected (0–68) | |
| 9 | 0–63 | Within expected (0–63) | |
| 34 | 0–62 | Within expected (0–62) | |
| 27 | 0–61 | Within expected (0–61) | |
| 29 | 0–54 | Within expected (0–54) | |
| 44 | 0–86 | Within expected (0–86) | |
| 46 | 0–66 | Within expected (0–66) | |
| 31 | 4–73 | Within expected (4–73) | |
| 43 | 2–70 | Within expected (2–70) | |
| 26 | 4–66 | Within expected (4–66) | |
| 66 | 17–54 | Above expected (17–54) | |
| 79 | 21–82 | Within expected (21–82) | |
| 78 | 19–81 | Within expected (19–81) | |
| 81 | 23–105 | Within expected (23–105) |
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 DQA.
Who has entered DQA in the last year?
3 companies filed in DQA for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Philips Medizin Systeme | K253887 | |
| Shenzhen Best Electronics Co., Ltd. | K253109 | |
| Shenzhen Ykd Technology Co., Ltd. | K251751 |
"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 DQA?
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 DQA?
Across the 726 most recent decisions, these applicants filed most often in DQA.
| Applicant | Recent clearances |
|---|---|
| Masimo Corporation | 49 |
| Nonin Medical, Inc. | 42 |
| Masimo Corp. | 28 |
| Beijing Choice Electronic Technololgy Co., Ltd. | 21 |
| Nellcor Puritan Bennett, Inc. | 19 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in DQA files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Masimo Corporation | 77 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch DQA
Get an email the morning anything changes in DQA — 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.