DJO SURGICAL
Model 804-06-213 · Encore Medical, L.P. · DI 00190446269366
FZX — Guide, Surgical, Instrument · Class I · 21 CFR 878.4800
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
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 | 1.58 |
| 2019-02 | 0 | 1.1 |
| 2019-03 | 0 | 1.13 |
| 2019-04 | 0 | 1.32 |
| 2019-05 | 0 | 1.5 |
| 2019-06 | 0 | 1.26 |
| 2019-07 | 0 | 1.38 |
| 2019-08 | 0 | 1.34 |
| 2019-09 | 0 | 1.38 |
| 2019-10 | 0 | 1.82 |
| 2019-11 | 0 | 1.48 |
| 2019-12 | 0 | 1.27 |
| 2020-01 | 0 | 1.68 |
| 2020-02 | 0 | 1.36 |
| 2020-03 | 0 | 1.74 |
| 2020-04 | 0 | 1.61 |
| 2020-05 | 0 | 1.5 |
| 2020-06 | 0 | 1.28 |
| 2020-07 | 0 | 2.03 |
| 2020-08 | 0 | 1.89 |
| 2020-09 | 0 | 1.73 |
| 2020-10 | 0 | 2.02 |
| 2020-11 | 0 | 1.91 |
| 2020-12 | 0 | 2.07 |
| 2021-01 | 0 | 2.03 |
| 2021-02 | 0 | 2.21 |
| 2021-03 | 0 | 1.54 |
| 2021-04 | 0 | 2.83 |
| 2021-05 | 0 | 2.91 |
| 2021-06 | 0 | 1.75 |
| 2021-07 | 0 | 1.63 |
| 2021-08 | 0 | 1.63 |
| 2021-09 | 0 | 1.62 |
| 2021-10 | 0 | 1.77 |
| 2021-11 | 0 | 2.05 |
| 2021-12 | 0 | 1.43 |
| 2022-01 | 0 | 1.4 |
| 2022-02 | 0 | 1.98 |
| 2022-03 | 0 | 1.83 |
| 2022-04 | 0 | 1.37 |
| 2022-05 | 0 | 1.62 |
| 2022-06 | 0 | 1.57 |
| 2022-07 | 0 | 2.17 |
| 2022-08 | 0 | 1.52 |
| 2022-09 | 0 | 1.78 |
| 2022-10 | 0 | 1.65 |
| 2022-11 | 0 | 1.9 |
| 2022-12 | 0 | 1.4 |
| 2023-01 | 0 | 2.44 |
| 2023-02 | 0 | 2.17 |
| 2023-03 | 0 | 2.09 |
| 2023-04 | 0 | 2.45 |
| 2023-05 | 0 | 2.51 |
| 2023-06 | 0 | 2.6 |
| 2023-07 | 0 | 1.92 |
| 2023-08 | 0 | 1.43 |
| 2023-09 | 0 | 1.4 |
| 2023-10 | 0 | 1.37 |
| 2023-11 | 0 | 1.5 |
| 2023-12 | 0 | 1.75 |
| 2024-01 | 0 | 1.39 |
| 2024-02 | 0 | 2.08 |
| 2024-03 | 0 | 1.43 |
| 2024-04 | 0 | 1.29 |
| 2024-05 | 0 | 1.44 |
| 2024-06 | 0 | 1.61 |
| 2024-07 | 0 | 1.56 |
| 2024-08 | 0 | 1.82 |
| 2024-09 | 0 | 1.91 |
| 2024-10 | 0 | 1.33 |
| 2024-11 | 0 | 1.46 |
| 2024-12 | 0 | 1.44 |
| 2025-01 | 0 | 1.46 |
| 2025-02 | 0 | 1.29 |
| 2025-03 | 0 | 1.34 |
| 2025-04 | 0 | 1.72 |
| 2025-05 | 0 | 1.33 |
| 2025-06 | 0 | 1.3 |
| 2025-07 | 0 | 1.36 |
| 2025-08 | 0 | 1.94 |
| 2025-09 | 0 | 1.45 |
| 2025-10 | 0 | 1.2 |
| 2025-11 | 0 | 1.52 |
| 2025-12 | 0 | 1.58 |
| 2026-01 | 0 | 1.74 |
| 2026-02 | 0 | 1.65 |
| 2026-03 | 0 | 1.67 |
| 2026-04 | 0 | 1.41 |
| 2026-05 | 0 | 1.47 |
| 2026-06 | 0 | 1.42 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K172351 — cites (transitively): K052906 (d1), K100741 (d1), K111061 (d1), K111735 (d1), K141006 (d1), K141990 (d1), K080402 (d2), K082120 (d2), K103208 (d2), K122698 (d2), K130048 (d2), K140904 (d2), K950594 (d2), K950651 (d2) — cited as predicate by K190290, K202098, K202611, K212737, K212800, K222317, K230572, K233712, K243955, K251184, K251558
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Encore Medical, L.P.
- VAI 2021-10-28 Encore Medical, LP · 2 citations
- NAI 2020-03-11 Encore Medical, LP · 0 citations
- NAI 2015-07-24 Encore Medical, LP · 0 citations
- VAI 2013-06-28 Encore Medical, LP · 2 citations