Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sedecal., Sa. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
99 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232185 | SM-IV | Sedecal., Sa. | 2023-08-21 | 28 | 0 |
| K222951 | SM-V | Sedecal., Sa. | 2022-11-21 | 55 | 0 |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | Sedecal., Sa. | 2022-07-18 | 26 | 1 |
| K212291 | PHOENIX | Sedecal., Sa. | 2021-09-14 | 54 | 1 |
| K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Ra | Sedecal., Sa. | 2021-02-01 | 60 | 0 |
| K202293 | Radiographic System Challenge X | Sedecal., Sa. | 2020-10-07 | 55 | 0 |
| K192936 | Soltus 500 | Sedecal., Sa. | 2019-11-15 | 28 | 1 |
| K192011 | PhoeniX | Sedecal., Sa. | 2019-09-25 | 58 | 0 |
| K191813 | MobileDiagnost wDR 2.2 | Sedecal., Sa. | 2019-08-02 | 28 | 4 |
| K173299 | DRAGON X SPSL4HC, DRAGON X SPSL8HC | Sedecal., Sa. | 2018-01-26 | 101 | 0 |
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM- | Sedecal., Sa. | 2016-07-06 | 54 | 13 |
| K141895 | MOBILEDIAGNOST WDR | Sedecal., Sa. | 2014-09-18 | 66 | 2 |
| K133782 | NOVA FA DR SYSTEM | Sedecal., Sa. | 2014-03-21 | 99 | 0 |
| K130883 | SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T | Sedecal., Sa. | 2013-04-18 | 20 | 0 |
| K121410 | DRAGON LW | Sedecal., Sa. | 2012-08-02 | 83 | 0 |
| K101517 | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY | Sedecal., Sa. | 2011-08-05 | 429 | 3 |
| K111725 | MOBILEDIAGNOST WDR | Sedecal., Sa. | 2011-07-19 | 29 | 5 |
| K103522 | SEDECAL | Sedecal., Sa. | 2011-01-26 | 56 | 0 |
| K090322 | EASY MOVING PLUS, SM-XXHF-YY | Sedecal., Sa. | 2009-03-17 | 36 | 31 |
| K090279 | SEDECAL, MILLENNIUM PLUS | Sedecal., Sa. | 2009-03-11 | 35 | 0 |
| K090238 | SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS | Sedecal., Sa. | 2009-02-27 | 25 | 0 |
| K063283 | DEFINIUM 5000 X-RAY SYSTEM | Sedecal., Sa. | 2006-11-17 | 18 | 3 |
| K062335 | SEDECAL X PLUS LP PLUS | Sedecal., Sa. | 2006-09-14 | 35 | 0 |
| K042876 | URS LP DIGITAL, MILLENNIUM, RADPRO | Sedecal., Sa. | 2004-11-18 | 31 | 0 |
| K043002 | SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR | Sedecal., Sa. | 2004-11-18 | 17 | 0 |
| K020436 | PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 | Sedecal., Sa. | 2002-02-22 | 14 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda