Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Madsen Electronics (Canada) , Ltd. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
321 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942749 | HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT | Madsen Electronics (Canada) , Ltd. | 1994-07-18 | 38 | 0 |
| K931325 | OTOACOUSTIC EMISSIONS UNIT CELESTA 503 | Madsen Electronics (Canada) , Ltd. | 1994-02-18 | 339 | 0 |
| K931324 | ORBITER 922 CLINICAL AUDIOMETER | Madsen Electronics (Canada) , Ltd. | 1993-11-19 | 248 | 0 |
| K910247 | ZODIAC 901 MIDDLE-EAR ANALYZER | Madsen Electronics (Canada) , Ltd. | 1991-06-19 | 148 | 0 |
| K884371 | MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM | Madsen Electronics (Canada) , Ltd. | 1989-02-13 | 118 | 0 |
| K884372 | MADSEN IGO1500 INSERTION GAIN OPTIMIZER | Madsen Electronics (Canada) , Ltd. | 1989-02-13 | 118 | 0 |
| K883478 | DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602 | Madsen Electronics (Canada) , Ltd. | 1988-11-17 | 93 | 0 |
| K874354 | AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020 | Madsen Electronics (Canada) , Ltd. | 1988-01-27 | 96 | 0 |
| K870229 | HEARING AID TEST SYSTEM MODEL HAT 1000 | Madsen Electronics (Canada) , Ltd. | 1987-03-13 | 51 | 0 |
| K861905 | PLOTTER MODEL (MP100) | Madsen Electronics (Canada) , Ltd. | 1986-11-26 | 194 | 0 |
| K854533 | SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2 | Madsen Electronics (Canada) , Ltd. | 1986-09-30 | 321 | 0 |
| K854535 | INSERTION GAIN OPTIMIZER IGO-1000 | Madsen Electronics (Canada) , Ltd. | 1986-02-20 | 99 | 0 |
| K854534 | DIGITAL SCREENING AUDIOMETER DSA6214 | Madsen Electronics (Canada) , Ltd. | 1986-02-13 | 92 | 0 |
| K845050 | UP800 A UNIVERSAL PRINTER | Madsen Electronics (Canada) , Ltd. | 1985-05-29 | 184 | 0 |
| K844592 | MTA 86 | Madsen Electronics (Canada) , Ltd. | 1985-05-22 | 177 | 0 |
| K845049 | Z0174, IMPEDANCE AUDIOMETER | Madsen Electronics (Canada) , Ltd. | 1985-05-21 | 176 | 0 |
| K844659 | VPS 2250, CSU2250 & VFU 2250 | Madsen Electronics (Canada) , Ltd. | 1985-02-25 | 91 | 0 |
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