Precision Dynamics Corporation
Valencia, CA, US
PRECISION DYNAMICS CORPORATION appears in FDA device records in Valencia, CA. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for Precision Dynamics Corporation between 1977 and 2016. The busiest year on record is 1977, with 6. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 6 |
| 1979 | 2 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 5 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 3 |
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161920 | Comfort Cover | IZH | Substantially Equivalent | |
| K020718 | SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE | HFW | Substantially Equivalent | |
| K994353 | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 | HFM | Substantially Equivalent | |
| K994263 | SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 | HFW | Substantially Equivalent | |
| K990737 | 'ECURLINE UMBILICAL CORD CLAMP #3500 | HFW | Substantially Equivalent | |
| K884357 | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | KOT | Substantially Equivalent | |
| K882580 | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE | JTW | Substantially Equivalent | |
| K874665 | SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY | LRP | Unknown | |
| K873369 | SECURLINE FRANSEENE NEEDLE | KNW | Substantially Equivalent | |
| K872507 | PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II | JSM | Substantially Equivalent | |
| K863164 | AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA | JSM | Substantially Equivalent | |
| K851364 | FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP | KNW | Substantially Equivalent | |
| K844634 | PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS | JSM | Substantially Equivalent | |
| K844865 | SECURLINE SURGICAL SKIN MARKER 1000 | FZZ | Substantially Equivalent | |
| K844370 | BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT | JSM | Substantially Equivalent | |
| K844369 | BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO | JSM | Substantially Equivalent | |
| K840820 | SECURLINE SURGICAL SKIN MARKER 1000 | FZZ | Substantially Equivalent | |
| K830235 | FRANZEN NEEDLE GUIDE | GDM | Substantially Equivalent | |
| K791953 | PDC 304 DOUBLE SWAB CULTURE COLLECTION | JTW | Substantially Equivalent | |
| K791924 | PDC 104 SINGLE SWAB CULTURE COLLECTION | JTW | Substantially Equivalent | |
| K772209 | CULTURE COLLEC. TRANS. SYS., DOUBLE DRY | JTW | Substantially Equivalent | |
| K772207 | CULTURE COLLEC. TRANS. SYS., SINGLE WET | JTW | Substantially Equivalent | |
| K772210 | CULTURE COLLEC. TRANS. SYS., DOUBLE WET | JTW | Substantially Equivalent | |
| K772208 | CULTURE COLLEC. TRANS. SYS., SINGLE DRY | JTW | Substantially Equivalent | |
| K772206 | CULTURE COLLEC. TRANS. SYS., SINGLE WET | JTW | Substantially Equivalent | |
| K772205 | CULTURE COLLEC. TRANS. SYS., DOUBLE WET | JTW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2020282 | 2020282 | PRECISION DYNAMICS CORPORATION | 25124 Springfield Ct Ste 200, Valencia, CA 91355 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NODBoard, Arm (With Cover), Non-Sterile
- KOTCarboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
- HFWClamp, Umbilical
- JSMCulture Media, Non-Propagating Transport
- KNWInstrument, Biopsy
- LYVLabel Or Tag, Sterile
- FZZMarker, Skin
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)
- GDMNeedle, Aspiration And Injection, Reusable
- JTWSystem, Transport, Aerobic
- IZHSystem, X-Ray, Mammographic
- LRPTray, Surgical
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1872-2013 | Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration. | PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain