Ludlow Technical Products: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ludlow Technical Products” (first 1993, latest 1999), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 87 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 | 0 | — |
| 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KXO | Monitor, Pressure, Intrauterine | 1 | 1 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | 1 | 1 |
Review panels
Most recent Ludlow Technical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991235 | SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) | KXO | 1999-07-08 | 87 |
| K973110 | LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD | GEI | 1997-10-21 | 62 |
| K972646 | AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES | NAE | 1997-08-21 | 37 |
| K964401 | KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) | FMT | 1997-02-06 | 94 |
| K931903 | SURELOCK(TM) SNAPLESS MONITORING ELECTRODE | DRX | 1993-10-07 | 175 |
Recalls
openFDA lists no recalls under a recalling firm named Ludlow Technical Products.
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.
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.
- Ludlow Corp., Technical Papers Division (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ludlow Technical Products?
FDA lists 5 510(k) clearances under the applicant name “Ludlow Technical Products” (first 1993, latest 1999), across 5 product codes in 4 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 Ludlow Technical Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ludlow Technical Products is 87 days.
Which FDA product codes appear under Ludlow Technical Products?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 1); FMT (Warmer, Infant Radiant, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 5 Ludlow Technical Products clearances with predicates and recalls
- Run predicate analysis for product code DRX, Ludlow Technical Products'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.