Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
J-Lloyd Medical, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
231 daysmedian FDA review time
367 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971504 | HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER | J-Lloyd Medical, Inc. | 1998-04-20 | 360 | 0 |
| K973639 | ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. | J-Lloyd Medical, Inc. | 1998-04-20 | 208 | 0 |
| K974335 | EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LL | J-Lloyd Medical, Inc. | 1998-02-13 | 87 | 0 |
| K974336 | CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC. | J-Lloyd Medical, Inc. | 1998-02-13 | 87 | 0 |
| K963248 | FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575- | J-Lloyd Medical, Inc. | 1997-02-03 | 168 | 0 |
| K950440 | DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LL | J-Lloyd Medical, Inc. | 1995-09-15 | 231 | 0 |
| K940547 | FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED | J-Lloyd Medical, Inc. | 1994-08-11 | 185 | 0 |
| K935405 | ARTERIAL EMBOLECTOMY | J-Lloyd Medical, Inc. | 1994-07-25 | 258 | 0 |
| K935403 | WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD | J-Lloyd Medical, Inc. | 1994-05-12 | 184 | 0 |
| K935404 | FLOW DIRECTED THERMODILUTION BALLOON CATHETER | J-Lloyd Medical, Inc. | 1994-05-03 | 175 | 0 |
| K935402 | ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD | J-Lloyd Medical, Inc. | 1994-04-26 | 168 | 0 |
| K930069 | BIPOLAR BALLOON PACING CATHETER BY J-LLOYD | J-Lloyd Medical, Inc. | 1994-01-28 | 387 | 0 |
| K920871 | J-LLOYD ARTERIAL EMBOLECTOMY CATHETER | J-Lloyd Medical, Inc. | 1993-02-26 | 367 | 0 |
| K920873 | WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD | J-Lloyd Medical, Inc. | 1993-01-14 | 324 | 0 |
| K920869 | FLOW DIRECTED THERMODILUTION BALLOON CATHETER | J-Lloyd Medical, Inc. | 1993-01-13 | 323 | 0 |
| K920870 | ANGIOGRAPHIC BALLOON CATHETER BY J LLOYD | J-Lloyd Medical, Inc. | 1993-01-07 | 317 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda