Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Electromed Intl., Ltd. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
156 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003688 | VIEW READING STATION | Electromed Intl., Ltd. | 2001-01-22 | 53 | 0 |
| K000474 | VIEW NT | Electromed Intl., Ltd. | 2000-04-19 | 65 | 0 |
| K990759 | VIEW COM | Electromed Intl., Ltd. | 1999-04-15 | 38 | 0 |
| K974255 | CD-R STATION AND VRS-2000 | Electromed Intl., Ltd. | 1998-01-27 | 75 | 0 |
| K971176 | VIEW ARCHIVING STATION | Electromed Intl., Ltd. | 1997-09-03 | 156 | 0 |
| K950694 | COMPACT-X | Electromed Intl., Ltd. | 1995-03-31 | 45 | 0 |
| K880050 | EDEC 60R | Electromed Intl., Ltd. | 1988-02-29 | 54 | 0 |
| K875341 | EDEC 60 R/F | Electromed Intl., Ltd. | 1988-02-01 | 33 | 0 |
| K875342 | EDEC 90C | Electromed Intl., Ltd. | 1988-01-29 | 30 | 0 |
| K871145 | EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR | Electromed Intl., Ltd. | 1987-03-31 | 8 | 0 |
| K870851 | EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR | Electromed Intl., Ltd. | 1987-03-20 | 17 | 0 |
| K864032 | EM TENS WINDOW ELECTRODES | Electromed Intl., Ltd. | 1986-12-22 | 68 | 0 |
| K863584 | EM II STRESS TEST ELECTRODE | Electromed Intl., Ltd. | 1986-12-08 | 84 | 0 |
| K863540 | EM II DISPOSABLE ELECTRODE | Electromed Intl., Ltd. | 1986-12-08 | 88 | 0 |
| K863845 | EM III DISPOSABLE ELECTRODE | Electromed Intl., Ltd. | 1986-11-20 | 50 | 0 |
| K862746 | EM DIAGNOSTIC ECG ELECTRODE | Electromed Intl., Ltd. | 1986-08-06 | 16 | 0 |
| K860827 | EM STRESS ELECTRODE | Electromed Intl., Ltd. | 1986-05-08 | 64 | 0 |
| K853774 | EM ELECTRODE | Electromed Intl., Ltd. | 1986-04-17 | 219 | 0 |
| K852908 | EDEC 2000 | Electromed Intl., Ltd. | 1985-11-29 | 143 | 0 |
| K843443 | EDEC-100 | Electromed Intl., Ltd. | 1985-03-01 | 178 | 0 |
| K823312 | CADIO-RESPIRATORY MONITOR #CR-2 | Electromed Intl., Ltd. | 1982-11-30 | 25 | 0 |
| K821959 | CARDIO-RESPIRATORY MONITOR MODEL CR-1 | Electromed Intl., Ltd. | 1982-07-20 | 20 | 0 |
| K812674 | INFANT CARIDAC MONITOR | Electromed Intl., Ltd. | 1981-10-13 | 21 | 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