Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Consultants Intl. , Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
233 daysmedian FDA review time
305 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904264 | MODEL SW-103 SOLITANS STIMULATOR | Medical Consultants Intl. , Ltd. | 1991-05-09 | 233 | 1 |
| K900731 | MEDI LISS DENTAL ANALGESIA DEVICE (SBL601) | Medical Consultants Intl. , Ltd. | 1990-12-17 | 305 | 0 |
| K903654 | LISS CRANIAL STIMULATOR MODEL SBL202-B | Medical Consultants Intl. , Ltd. | 1990-10-04 | 90 | 1 |
| K902976 | MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC | Medical Consultants Intl. , Ltd. | 1990-09-07 | 63 | 0 |
| K894515 | LISS CRANIAL STIMULATOR MODEL SBL201-M | Medical Consultants Intl. , Ltd. | 1990-05-03 | 288 | 0 |
| K896226 | LISS BODY STIMULATOR MODEL SBL501-M | Medical Consultants Intl. , Ltd. | 1990-04-10 | 161 | 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