Patient Monitor
Model X12s · Edan Instruments, Inc. · DI 06944413814769
CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase · Class II · 21 CFR 868.1400
DQA — Oximeter · Class II · 21 CFR 870.2700
DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) · Class II · 21 CFR 870.2300
DSB — Plethysmograph, Impedance · Class II · 21 CFR 870.2770
DSI — Detector And Alarm, Arrhythmia · Class II · 21 CFR 870.1025
DSK — Computer, Blood-Pressure · Class II · 21 CFR 870.1110
DXN — System, Measurement, Blood-Pressure, Non-Invasive · Class II · 21 CFR 870.1130
FLL — Continuous Measurement Thermometer · Class II · 21 CFR 880.2910
MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.1025
MLD — Monitor, St Segment With Alarm · Class II · 21 CFR 870.1025
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2025-10-24 | Z-1148-2026 | Class II | Open, Classified | 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. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 11.78 |
| 2019-02 | 0 | 9.36 |
| 2019-03 | 0 | 11.34 |
| 2019-04 | 0 | 9.4 |
| 2019-05 | 0 | 8.58 |
| 2019-06 | 0 | 7.99 |
| 2019-07 | 0 | 9.49 |
| 2019-08 | 0 | 8.49 |
| 2019-09 | 0 | 11.31 |
| 2019-10 | 0 | 9.88 |
| 2019-11 | 0 | 10.66 |
| 2019-12 | 0 | 10.21 |
| 2020-01 | 0 | 9.24 |
| 2020-02 | 0 | 9.32 |
| 2020-03 | 0 | 10.18 |
| 2020-04 | 0 | 10.04 |
| 2020-05 | 0 | 7.53 |
| 2020-06 | 0 | 8.28 |
| 2020-07 | 0 | 7.74 |
| 2020-08 | 0 | 9.6 |
| 2020-09 | 0 | 9.89 |
| 2020-10 | 0 | 9.48 |
| 2020-11 | 0 | 16.75 |
| 2020-12 | 0 | 19.63 |
| 2021-01 | 0 | 15.23 |
| 2021-02 | 0 | 10.24 |
| 2021-03 | 0 | 12.89 |
| 2021-04 | 0 | 11.89 |
| 2021-05 | 0 | 9.33 |
| 2021-06 | 0 | 10.96 |
| 2021-07 | 0 | 10.03 |
| 2021-08 | 0 | 10.68 |
| 2021-09 | 0 | 9.88 |
| 2021-10 | 0 | 9.68 |
| 2021-11 | 0 | 10.47 |
| 2021-12 | 0 | 10.8 |
| 2022-01 | 0 | 9.97 |
| 2022-02 | 0 | 9.98 |
| 2022-03 | 0 | 11.71 |
| 2022-04 | 0 | 10.32 |
| 2022-05 | 0 | 12.12 |
| 2022-06 | 0 | 7.82 |
| 2022-07 | 0 | 7.31 |
| 2022-08 | 0 | 9.14 |
| 2022-09 | 0 | 9.53 |
| 2022-10 | 0 | 11.81 |
| 2022-11 | 0 | 8.79 |
| 2022-12 | 0 | 10.27 |
| 2023-01 | 0 | 8.12 |
| 2023-02 | 0 | 13.47 |
| 2023-03 | 0 | 16.11 |
| 2023-04 | 0 | 14.52 |
| 2023-05 | 0 | 14.7 |
| 2023-06 | 0 | 11.98 |
| 2023-07 | 0 | 17.2 |
| 2023-08 | 0 | 18.48 |
| 2023-09 | 0 | 18.8 |
| 2023-10 | 0 | 12.88 |
| 2023-11 | 0 | 16.17 |
| 2023-12 | 0 | 15.92 |
| 2024-01 | 0 | 16.68 |
| 2024-02 | 0 | 15.26 |
| 2024-03 | 0 | 16.79 |
| 2024-04 | 0 | 11.08 |
| 2024-05 | 0 | 12.9 |
| 2024-06 | 0 | 10.79 |
| 2024-07 | 0 | 13.71 |
| 2024-08 | 0 | 13.73 |
| 2024-09 | 0 | 15.94 |
| 2024-10 | 0 | 19.69 |
| 2024-11 | 0 | 14.63 |
| 2024-12 | 0 | 13.25 |
| 2025-01 | 0 | 15.59 |
| 2025-02 | 0 | 12.85 |
| 2025-03 | 0 | 16.42 |
| 2025-04 | 0 | 11.72 |
| 2025-05 | 0 | 11.9 |
| 2025-06 | 0 | 10.86 |
| 2025-07 | 0 | 13.81 |
| 2025-08 | 0 | 10.11 |
| 2025-09 | 0 | 9 |
| 2025-10 | 0 | 14.4 |
| 2025-11 | 0 | 10.52 |
| 2025-12 | 0 | 11.84 |
| 2026-01 | 0 | 11.25 |
| 2026-02 | 0 | 12.46 |
| 2026-03 | 0 | 12.77 |
| 2026-04 | 0 | 19.12 |
| 2026-05 | 0 | 16.16 |
| 2026-06 | 0 | 15.11 |
Regulatory clearances
- K192514 SESE 2020-04-02 (k number procode)
Predicate lineage
K192514 — cites (transitively): K160981 (d1), K182075 (d1), K182821 (d1), K011291 (d2), K042346 (d2), K042536 (d2), K051212 (d2), K170712 (d2), K132038 (d3), K152902 (d3), K072235 (d4), K101521 (d4), K143195 (d4), K150352 (d4), K150632 (d4), K003621 (d5), K030738 (d5), K073376 (d5), K092449 (d5), K123074 (d5), K132026 (d5), K132037 (d5), K132075 (d5), K020550 (d5), K062098 (d5), K070791 (d5), K091834 (d5), K132036 (d5), K132662 (d5), K142601 (d5), K080192 (d6), K091786 (d6), K102562 (d6), K031760 (d6), K021778 (d7), K030038 (d7), K032858 (d7), K033444 (d7), K041235 (d7), K050762 (d7), K053522 (d7), K082633 (d7), K100939 (d7) — cited as predicate by K202336, K202892, K220308
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Edan Instruments, Inc.
- NAI 2012-11-29 Edan Instruments, Inc. · 0 citations
- NAI 2012-11-29 Edan Instruments, Inc. · 0 citations