Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Parker Laboratories, Inc. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
244 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | 2024-08-15 | 244 | 0 |
| K953673 | ECLIPSE PROBE COVER | Parker Laboratories, Inc. | 1996-03-14 | 220 | 1 |
| K921695 | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS | Parker Laboratories, Inc. | 1995-02-23 | 1051 | 0 |
| K864556 | AQUALUBE(TM) | Parker Laboratories, Inc. | 1986-12-01 | 12 | 0 |
| K861239 | ACRYLIC SOLDER | Parker Laboratories, Inc. | 1986-04-17 | 15 | 0 |
| K855167 | DYNA SYSTEM | Parker Laboratories, Inc. | 1986-03-04 | 68 | 0 |
| K851895 | POLYGEL ULTRASOUND GEL | Parker Laboratories, Inc. | 1985-09-27 | 150 | 0 |
| K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION | Parker Laboratories, Inc. | 1985-08-09 | 29 | 3 |
| K841400 | NEURO PULSE | Parker Laboratories, Inc. | 1984-06-15 | 73 | 0 |
| K840548 | RESIL | Parker Laboratories, Inc. | 1984-04-17 | 69 | 0 |
| K831039 | COMPLUS VARIOUS FORMS | Parker Laboratories, Inc. | 1983-05-27 | 57 | 0 |
| K822711 | ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL | Parker Laboratories, Inc. | 1982-11-03 | 57 | 0 |
| K822896 | CAVIDRY | Parker Laboratories, Inc. | 1982-10-22 | 23 | 0 |
| K827296 | POLYSONIC ULTRASOUND LOTION | Parker Laboratories, Inc. | 1982-04-16 | 17 | 0 |
| K811995 | FORAMATRON APICAL FORAMEN LOCATOR | Parker Laboratories, Inc. | 1981-09-21 | 70 | 0 |
| K802146 | AQUASONIC 100 ULTRASOUND TRANS. GEL, | Parker Laboratories, Inc. | 1980-10-10 | 35 | 0 |
| K800060 | PROVIT | Parker Laboratories, Inc. | 1980-01-23 | 13 | 0 |
| K790555 | HEMO-WEDGE | Parker Laboratories, Inc. | 1980-01-17 | 304 | 0 |
| K792391 | COTTON ROLL COMPRESSION CAPS | Parker Laboratories, Inc. | 1979-12-06 | 10 | 0 |
| K791013 | SPECTRA R PAD | Parker Laboratories, Inc. | 1979-09-17 | 108 | 0 |
| K790638 | ACCUTRON POLLUTION REDUCER | Parker Laboratories, Inc. | 1979-05-25 | 56 | 0 |
| K782055 | CREAM, SIGNA | Parker Laboratories, Inc. | 1979-03-21 | 100 | 0 |
| K781351 | AURO-BRUSH | Parker Laboratories, Inc. | 1978-12-04 | 119 | 0 |
| K780973 | SIGNAPAD | Parker Laboratories, Inc. | 1978-07-27 | 45 | 0 |
| K771527 | ACCU. CROWN COLD CURE | Parker Laboratories, Inc. | 1977-08-16 | 8 | 0 |
| K771130 | DESENSITRON | Parker Laboratories, Inc. | 1977-07-15 | 22 | 0 |
| K771011 | ARTICULATING PAPER | Parker Laboratories, Inc. | 1977-06-20 | 14 | 0 |
| K770685 | LIGHT, EXAMINING, DENTAL, ULTRA VIOLET | Parker Laboratories, Inc. | 1977-04-26 | 14 | 0 |
| K770684 | CROWN, ACRYLIC, CORAL BRAND, PREFORMED | Parker Laboratories, Inc. | 1977-04-26 | 14 | 0 |
| K770067 | CYANOBOND | Parker Laboratories, Inc. | 1977-01-25 | 13 | 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