Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Precision Dynamics Corp. — Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
68 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020718 | SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERI | Precision Dynamics Corp. | 2002-06-03 | 90 | 0 |
| K994353 | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #356 | Precision Dynamics Corp. | 2000-03-22 | 90 | 0 |
| K994263 | SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 | Precision Dynamics Corp. | 2000-01-24 | 38 | 0 |
| K990737 | 'ECURLINE UMBILICAL CORD CLAMP #3500 | Precision Dynamics Corp. | 1999-04-06 | 32 | 0 |
| K884357 | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | Precision Dynamics Corp. | 1988-11-01 | 15 | 0 |
| K882580 | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE | Precision Dynamics Corp. | 1988-07-08 | 17 | 0 |
| K874665 | SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY | Precision Dynamics Corp. | 1988-01-20 | 68 | 0 |
| K873369 | SECURLINE FRANSEENE NEEDLE | Precision Dynamics Corp. | 1987-10-20 | 60 | 0 |
| K872507 | PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II | Precision Dynamics Corp. | 1987-07-09 | 15 | 0 |
| K863164 | AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA | Precision Dynamics Corp. | 1986-08-27 | 9 | 0 |
| K851364 | FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP | Precision Dynamics Corp. | 1985-04-22 | 18 | 0 |
| K844634 | PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS | Precision Dynamics Corp. | 1985-01-30 | 64 | 0 |
| K844865 | SECURLINE SURGICAL SKIN MARKER 1000 | Precision Dynamics Corp. | 1985-01-14 | 31 | 0 |
| K844369 | BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO | Precision Dynamics Corp. | 1985-01-04 | 52 | 0 |
| K844370 | BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT | Precision Dynamics Corp. | 1985-01-04 | 52 | 0 |
| K840820 | SECURLINE SURGICAL SKIN MARKER 1000 | Precision Dynamics Corp. | 1984-04-25 | 61 | 0 |
| K830235 | FRANZEN NEEDLE GUIDE | Precision Dynamics Corp. | 1983-02-23 | 29 | 0 |
| K791953 | PDC 304 DOUBLE SWAB CULTURE COLLECTION | Precision Dynamics Corp. | 1979-10-30 | 29 | 0 |
| K791924 | PDC 104 SINGLE SWAB CULTURE COLLECTION | Precision Dynamics Corp. | 1979-10-17 | 20 | 0 |
| K772209 | CULTURE COLLEC. TRANS. SYS., DOUBLE DRY | Precision Dynamics Corp. | 1977-12-20 | 19 | 0 |
| K772207 | CULTURE COLLEC. TRANS. SYS., SINGLE WET | Precision Dynamics Corp. | 1977-12-20 | 19 | 0 |
| K772206 | CULTURE COLLEC. TRANS. SYS., SINGLE WET | Precision Dynamics Corp. | 1977-12-09 | 8 | 0 |
| K772210 | CULTURE COLLEC. TRANS. SYS., DOUBLE WET | Precision Dynamics Corp. | 1977-12-09 | 8 | 0 |
| K772205 | CULTURE COLLEC. TRANS. SYS., DOUBLE WET | Precision Dynamics Corp. | 1977-12-09 | 8 | 0 |
| K772208 | CULTURE COLLEC. TRANS. SYS., SINGLE DRY | Precision Dynamics Corp. | 1977-12-09 | 8 | 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