Phadia 250
Model 12-3900-01 · Phadia AB · DI 07333066001029
DHB — System, Test, Radioallergosorbent (Rast) Immunological · Class II · 21 CFR 866.5750
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 (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (3)
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.
Injury: 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-07 | 0 | 1 |
| 2021-02 | 0 | 7 |
| 2023-03 | 0 | 1 |
| 2024-06 | 0 | 2 |
| 2024-11 | 0 | 1 |
| 2025-10 | 0 | 2 |
| 2026-03 | 3 | 3 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K051218 — cited as predicate by K151029, K182479, K190315, K191510, K200279, K200825, K212181, K220162, K242531, K252493, K252775, K260059, K260280, K260591, K261027
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Phadia AB
- NAI 2013-11-21 Phadia GmbH · 0 citations
- NAI 2011-08-18 Phadia Ab · 0 citations
- NAI 2011-08-18 Phadia Ab · 0 citations