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FDA product code · Anesthesiology · Class 2

DQA: Oximeter

DQA is FDA's product code for "Oximeter": a Class 2 device classified under 21 CFR 870.2700, reviewed by the Anesthesiology panel.

510(k) review time for DQA

Across 131 510(k) clearances under DQA decided from 2018-01-01 to 2026-10-06, the median was 210 days from FDA receipt to decision. Half took between 148 and 296 days, and 80% were decided within 317 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, DQA, decisions 2018-01-01 to 2026-10-06 (n = 131)
Fastest25
25th percentile148
Median210
75th percentile296
80th percentile317
90th percentile408
Slowest822
Median days by decision year, DQA (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
201826018
201915819
202012615
202117410
202226520
202331713
202428514
202518215
2026 (to 10-06, partial)1677

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

DQA in the public FDA record

Records naming DQA, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years726
Device recalls128
Establishment listings1,368
GUDID device identifiers9,929

Counts of records, not of devices or events. Adverse event reports for DQA are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite DQA

2 FDA recognized consensus standards cite DQA, 1 of them recognized only in part, among them ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02); IEEE Std 11073-10404-2020. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 1-139 ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) (partial recognition) — Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
  • 13-134 IEEE Std 11073-10404-2020 — Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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