Deknatel, Inc.: FDA filings under this applicant name
FDA lists 37 510(k) clearances under the applicant name “Deknatel, Inc.” (first 1976, latest 1997), across 18 product codes in 7 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | 11 | 11 |
| KDQ | Bottle, Collection, Vacuum | 5 | 5 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 4 | 4 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | 2 |
| JOL | Catheter And Tip, Suction | 2 | 2 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| GAL | Suture, Absorbable, Natural | 1 | 1 |
| GAP | Suture, Nonabsorbable, Silk | 1 | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 | 1 |
Plus 8 more product codes.
Review panels
- Cardiovascular (14)
- General Hospital (12)
- General and Plastic Surgery (7)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
- Ophthalmic (1)
- Physical Medicine (1)
Most recent Deknatel, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963850 | PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM | CAC | 1997-04-22 | 209 |
| K962683 | SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR | HIF | 1997-01-10 | 184 |
| K964070 | DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG | CAC | 1996-12-31 | 82 |
| K963098 | PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100) | CAC | 1996-11-08 | 91 |
| K962856 | PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR | KDQ | 1996-08-28 | 37 |
| K925243 | DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER | GBX | 1994-07-27 | 649 |
| K930740 | SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL | GAQ | 1994-07-26 | 529 |
| K930739 | SUTURES POLYPROP., POLYETHELINE, NYLON & SILK | GAP | 1994-07-26 | 529 |
| K930738 | SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC | GAL | 1994-07-26 | 529 |
| K926338 | PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F | CAC | 1994-07-26 | 585 |
27 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Deknatel, 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 Deknatel, Inc.?
FDA lists 37 510(k) clearances under the applicant name “Deknatel, Inc.” (first 1976, latest 1997), across 18 product codes in 7 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 Deknatel, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Deknatel, Inc. is 82 days.
Which FDA product codes appear under Deknatel, Inc.?
The most frequent FDA product codes under this applicant name are CAC (Apparatus, Autotransfusion, 11); KDQ (Bottle, Collection, Vacuum, 5); GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered, 4).
Next steps
- See all 37 Deknatel, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAC, Deknatel, 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.