Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elmed, Inc. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
399 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010465 | DENSTAT | Elmed, Inc. | 2001-05-14 | 87 | 0 |
| K974793 | ELMED ESU 120 M/M DIGITAL | Elmed, Inc. | 1998-03-19 | 87 | 0 |
| K953271 | ELMED RF-ALERT | Elmed, Inc. | 1996-01-18 | 189 | 0 |
| K952110 | ELMED THERMO-FLUX | Elmed, Inc. | 1995-08-14 | 101 | 0 |
| K926517 | ELMED LBC 50-P | Elmed, Inc. | 1994-11-15 | 685 | 0 |
| K932938 | ELMED ESU 300 M/M AND DIGITAL | Elmed, Inc. | 1994-05-02 | 320 | 0 |
| K921770 | ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M | Elmed, Inc. | 1993-05-17 | 399 | 0 |
| K915731 | ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL | Elmed, Inc. | 1992-11-05 | 321 | 0 |
| K905417 | ELMED PNEUMOMAT DIGITAL | Elmed, Inc. | 1991-01-31 | 58 | 0 |
| K881431 | SIEMENS STEREODYNATOR 828 | Elmed, Inc. | 1990-04-16 | 741 | 0 |
| K875238 | SIEMENS NEUROTON 826 AND 827 | Elmed, Inc. | 1988-03-10 | 79 | 0 |
| K872909 | SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION | Elmed, Inc. | 1988-01-13 | 173 | 0 |
| K862589 | ULTRATHERM 808 I | Elmed, Inc. | 1986-08-01 | 25 | 0 |
| K862029 | SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT | Elmed, Inc. | 1986-07-16 | 49 | 0 |
| K852034 | VITATRON M | Elmed, Inc. | 1986-01-03 | 239 | 0 |
| K832589 | ELMED WMC 10 AND BC 50 M/M | Elmed, Inc. | 1984-04-23 | 265 | 0 |
| K840321 | ENDODYNE DUAL | Elmed, Inc. | 1984-03-16 | 51 | 0 |
| K832393 | ENCODYNE 4 & VACUFIX 4 | Elmed, Inc. | 1983-11-14 | 118 | 0 |
| K810529 | DIRECT WRITING VECTORCARDIOGRAPH | Elmed, Inc. | 1981-04-23 | 56 | 0 |
| K791279 | KOLPOSKOP KP20005 | Elmed, Inc. | 1979-09-17 | 69 | 0 |
| K791280 | OPERATION MICROSCOPE SOM 1 | Elmed, Inc. | 1979-07-24 | 14 | 0 |
| K790794 | SIEMENS CARDIOSTAT 701 | Elmed, Inc. | 1979-05-31 | 37 | 0 |
| K790033 | HVG-100 | Elmed, Inc. | 1979-02-09 | 37 | 0 |
| K781455 | SIEMENS ULTRATHERM 708 | Elmed, Inc. | 1978-12-07 | 106 | 0 |
| K770782 | FIBERSCOPIC SCOPE RECORDER SYSTEM | Elmed, Inc. | 1977-05-06 | 4 | 0 |
| K770777 | THERMOMETER, ELECTRONIC, DIGIMED HOL | Elmed, Inc. | 1977-05-03 | 5 | 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