Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Instromedix, Inc. — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
163 daysmedian FDA review time
315 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964408 | POSEIDON CARDIAC MONITORING SYSTEM (PCMS) | Instromedix, Inc. | 1997-07-23 | 261 | 0 |
| K964036 | CARDIOMAGIC 2000 SOFTWARE | Instromedix, Inc. | 1997-07-18 | 283 | 0 |
| K955060 | ACCELERATED TRANSMISSION PROTOCOL | Instromedix, Inc. | 1996-04-08 | 158 | 0 |
| K951096 | LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER | Instromedix, Inc. | 1996-01-16 | 315 | 0 |
| K945476 | HEARTHWATCH III(TM) | Instromedix, Inc. | 1995-11-09 | 366 | 0 |
| K950003 | CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS | Instromedix, Inc. | 1995-10-31 | 301 | 0 |
| K944362 | HEARTCARD CARDIAC EVENT MONITOR | Instromedix, Inc. | 1995-09-07 | 365 | 0 |
| K943931 | CARRYALL ENHANCEMENTS | Instromedix, Inc. | 1995-04-04 | 235 | 0 |
| K935586 | PRINCE | Instromedix, Inc. | 1994-11-08 | 363 | 0 |
| K925639 | CARDIOMAGIC SOFTWARE | Instromedix, Inc. | 1993-06-22 | 225 | 0 |
| K923221 | KING OF HEARTS SCEPTER | Instromedix, Inc. | 1993-03-08 | 250 | 0 |
| K925809 | COMPRESSAR UNIVERSAL (TM) SYSTEM | Instromedix, Inc. | 1993-02-22 | 97 | 0 |
| K920984 | KING OF HEARTS EXPRESS (E.X.) MONITOR | Instromedix, Inc. | 1992-10-14 | 226 | 0 |
| K896040 | KING OF HEARTS CDM | Instromedix, Inc. | 1990-05-15 | 211 | 0 |
| K896039 | KING OF HEARTS 1200 MONITOR | Instromedix, Inc. | 1990-02-28 | 135 | 0 |
| K896002 | CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER | Instromedix, Inc. | 1990-01-19 | 98 | 0 |
| K891000 | MODIFIED EXTERNAL PAD | Instromedix, Inc. | 1989-05-19 | 81 | 0 |
| K881297 | BARO-GRAF 24 | Instromedix, Inc. | 1988-09-16 | 172 | 0 |
| K880626 | KING OF HEARTS | Instromedix, Inc. | 1988-04-11 | 55 | 0 |
| K844310 | BLOOD-PRESSURE ECG TRANSMITTER | Instromedix, Inc. | 1985-04-18 | 163 | 0 |
| K842051 | EKG TRANSMITTER MODEL 5134 | Instromedix, Inc. | 1985-03-01 | 283 | 0 |
| K840587 | INSTANT REPLAY | Instromedix, Inc. | 1984-10-26 | 261 | 0 |
| K833809 | NEURAL STIMULATOR MONITOR | Instromedix, Inc. | 1983-12-01 | 29 | 0 |
| K831337 | COMPRESSAR DISPOSABLE DISC | Instromedix, Inc. | 1983-07-19 | 85 | 0 |
| K830477 | CARDIOMEMO III | Instromedix, Inc. | 1983-05-09 | 83 | 0 |
| K803286 | CARDIOMEMO | Instromedix, Inc. | 1981-03-17 | 77 | 0 |
| K800696 | ELECTRONIC PACEMAKER WAVEFORM ANALYZER | Instromedix, Inc. | 1980-08-14 | 139 | 0 |
| K800405 | A-V MINI CLINIC | Instromedix, Inc. | 1980-07-21 | 146 | 0 |
| K791892 | TAPE-A-TRACE | Instromedix, Inc. | 1979-11-05 | 41 | 0 |
| K791762 | SELF CHECK | Instromedix, Inc. | 1979-09-21 | 24 | 0 |
| K781349 | PACER-TRACER PULSE WIDTH | Instromedix, Inc. | 1978-08-31 | 24 | 0 |
| K771922 | MINICLINIC TM | Instromedix, Inc. | 1977-11-02 | 20 | 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