Precision Dynamics Corp.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under 2 spellings of the applicant name “Precision Dynamics Corp.” (first 1977, latest 2016), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 24 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 2 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JTW | System, Transport, Aerobic | 9 | 9 |
| JSM | Culture Media, Non-Propagating Transport | 5 | 5 |
| HFW | Clamp, Umbilical | 3 | 3 |
| FZZ | Marker, Skin | 2 | 2 |
| KNW | Instrument, Biopsy | 2 | 2 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 | 1 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | 1 | 1 |
| LRP | Tray, Surgical | 1 | 1 |
Review panels
- Microbiology (14)
- General and Plastic Surgery (6)
- Obstetrics and Gynecology (4)
- Dental (1)
- Radiology (1)
Most recent Precision Dynamics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161920 | Comfort Cover | IZH | 2016-07-15 | 2 |
| K020718 | SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE | HFW | 2002-06-03 | 90 |
| K994353 | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 | HFM | 2000-03-22 | 90 |
| K994263 | SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 | HFW | 2000-01-24 | 38 |
| K990737 | 'ECURLINE UMBILICAL CORD CLAMP #3500 | HFW | 1999-04-06 | 32 |
| K884357 | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | KOT | 1988-11-01 | 15 |
| K882580 | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE | JTW | 1988-07-08 | 17 |
| K874665 | SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY | LRP | 1988-01-20 | 68 |
| K873369 | SECURLINE FRANSEENE NEEDLE | KNW | 1987-10-20 | 60 |
| K872507 | PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II | JSM | 1987-07-09 | 15 |
16 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-07-10.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Precision Dynamics Corp. (25)
- Precision Dynamics Corporation (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Precision Medical, Inc. (30 510(k)s)
- Precision Spine, Inc. (26 510(k)s)
- Precision Biologicals, Inc. (20 510(k)s)
- Precision Biologic (17 510(k)s)
- Precision Med Products, Ltd. (16 510(k)s)
- Precision Acoustics Ind., Inc. (9 510(k)s)
- Precision Cap Systems (7 510(k)s)
- Precision Vascular Systems, Inc. (7 510(k)s)
- Precision-Cosmet Co., Inc. (4 510(k)s)
- Precision Instruments, Inc. (4 510(k)s)
- Precision Laser Products, Inc. (4 510(k)s)
- Precision Medical Instruments, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Precision Dynamics Corp.?
FDA lists 26 510(k) clearances under 2 spellings of the applicant name “Precision Dynamics Corp.” (first 1977, latest 2016), across 10 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Precision Dynamics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Precision Dynamics Corp. is 24 days.
Which FDA product codes appear under Precision Dynamics Corp.?
The most frequent FDA product codes under this applicant name are JTW (System, Transport, Aerobic, 9); JSM (Culture Media, Non-Propagating Transport, 5); HFW (Clamp, Umbilical, 3).
Next steps
- See all 26 Precision Dynamics Corp. clearances with predicates and recalls
- Run predicate analysis for product code JTW, Precision Dynamics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.