Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DQC — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
147 daysmedian FDA review time
315 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950537 | CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH | Cardiophonics, Inc. | 1996-03-01 | 388 | 0 |
| K952651 | LIFE SOUND SENSOR | Flowscan, Inc. | 1995-09-19 | 102 | 0 |
| K943726 | ACOUSTIC RECORDER | Technology Applications Assoc., Inc. | 1994-11-30 | 120 | 0 |
| K924054 | PHONOCARDIOGRAPH | Echo Ultrasound | 1993-01-22 | 163 | 0 |
| K902185 | DYNAMIC SPECTRAL PHONOCARDIOGRAPH | Reeves Scientific, Inc. | 1991-03-25 | 315 | 0 |
| K900560 | ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE | Acuson Corp. | 1990-12-03 | 299 | 0 |
| K900365 | PAG MICROPROCESSOR-CONTROLLED MODULE | Life Sciences Manufacturing, Inc. | 1990-07-18 | 174 | 0 |
| K873640 | MODIFIED DSP100 AMPLIFIER | Intl. Acoustics, Inc. | 1987-12-07 | 89 | 0 |
| K870545 | ANDRIES PHYSICAL ASSESSMENT COMPUTER | Andries Tek, Inc. | 1987-08-14 | 185 | 0 |
| K864429 | DSP100 CAROTID PHONOANGIOGRAPHY MODULE | Intl. Acoustics, Inc. | 1987-05-12 | 181 | 0 |
| K860814 | DSP100 AMPLIFIER | Intl. Acoustics, Inc. | 1986-12-05 | 276 | 0 |
| K832679 | NON-INVASIVE CLINICAL VASCULAR LAB | Life Sciences Manufacturing, Inc. | 1984-01-03 | 147 | 0 |
| K811626 | MEDDARS/ULTRA IMAGER PULSE/PHON MODULE | Honeywell, Inc. | 1981-07-01 | 22 | 0 |
| K800655 | MODEL 100 SPECTRAVIEW | Edwards Laboratories | 1980-04-16 | 22 | 0 |
| K792466 | NIC-200 VENTRICULAR FUNCTION ANALYZER | Nicolet Biomedical Instruments | 1980-01-24 | 52 | 0 |
| K780116 | AMPLIFIER, PC-700 | Burdick Corp. | 1978-02-24 | 35 | 0 |
| K770757 | PULSE/PHONOCARDIOGRAPHY CHANNEL, 144 | Honeywell, Inc. | 1977-05-09 | 14 | 0 |
| K760464 | PHON/STRESS SYSTEM (#21126A) | Hewlett-Packard Co. | 1976-08-30 | 12 | 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