Dlp, Inc.: FDA filings under this applicant name
FDA lists 56 510(k) clearances under the applicant name “Dlp, Inc.” (first 1979, latest 1997), across 23 product codes in 3 review panels. Median 510(k) review time under this name: 69 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 22 | 22 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 5 | 5 |
| GAA | Needle, Aspiration And Injection, Disposable | 5 | 5 |
| KNW | Instrument, Biopsy | 3 | 3 |
| DQX | Wire, Guide, Catheter | 2 | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 2 | 2 |
| DQT | Occluder, Catheter Tip | 1 | 1 |
| DRA | Catheter, Steerable | 1 | 1 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 | 1 |
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | 1 | 1 |
Plus 13 more product codes.
Review panels
Most recent Dlp, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973485 | CLEARVIEW BLOWER/MISTER | FQH | 1997-12-08 | 84 |
| K964445 | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | DWS | 1997-01-30 | 85 |
| K953945 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET | DWF | 1996-03-26 | 218 |
| K950754 | MACRO SUCTION TUBE MODEL NO 10061 | GCY | 1995-04-25 | 67 |
| K934215 | CONTAIN-OR | KKX | 1994-02-09 | 163 |
| K915268 | CATHETER TWO STAGE VENOUS RETURN | DWF | 1992-07-27 | 245 |
| K914608 | BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 | GAA | 1992-01-09 | 84 |
| K913077 | LANCASTER COOLING JACKET, CAT. CODE #13500/13501 | DTR | 1992-01-09 | 182 |
| K913098 | APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 | KNW | 1991-11-05 | 116 |
| K912229 | IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003 | GEI | 1991-09-25 | 128 |
46 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dlp, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dlp, Inc.?
FDA lists 56 510(k) clearances under the applicant name “Dlp, Inc.” (first 1979, latest 1997), across 23 product codes in 3 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 Dlp, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dlp, Inc. is 69 days.
Which FDA product codes appear under Dlp, Inc.?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 22); DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, 5); GAA (Needle, Aspiration And Injection, Disposable, 5).
Next steps
- See all 56 Dlp, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWF, Dlp, Inc.'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.