J-Lloyd Medical, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “J-Lloyd Medical, Inc.” (first 1993, latest 1998), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 220 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 5 | 5 |
| DYG | Catheter, Flow Directed | 4 | 4 |
| DXE | Catheter, Embolectomy | 3 | 3 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| LDF | Electrode, Pacemaker, Temporary | 1 | 1 |
Review panels
Most recent J-Lloyd Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973639 | ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. | DRF | 1998-04-20 | 208 |
| K971504 | HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER | DRF | 1998-04-20 | 360 |
| K974336 | CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC. | GCJ | 1998-02-13 | 87 |
| K974335 | EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. | DXE | 1998-02-13 | 87 |
| K963248 | FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) | DYG | 1997-02-03 | 168 |
| K950440 | DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD | DQO | 1995-09-15 | 231 |
| K940547 | FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED | DYG | 1994-08-11 | 185 |
| K935405 | ARTERIAL EMBOLECTOMY | DXE | 1994-07-25 | 258 |
| K935403 | WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD | DQO | 1994-05-12 | 184 |
| K935404 | FLOW DIRECTED THERMODILUTION BALLOON CATHETER | DYG | 1994-05-03 | 175 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named J-Lloyd Medical, 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 J-Lloyd Medical, Inc.?
FDA lists 16 510(k) clearances under the applicant name “J-Lloyd Medical, Inc.” (first 1993, latest 1998), across 6 product codes in 2 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 J-Lloyd Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name J-Lloyd Medical, Inc. is 220 days.
Which FDA product codes appear under J-Lloyd Medical, Inc.?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 5); DYG (Catheter, Flow Directed, 4); DXE (Catheter, Embolectomy, 3).
Next steps
- See all 16 J-Lloyd Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQO, J-Lloyd Medical, 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.