Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reshape Lifesciences · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241039 | ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape | Reshape Lifesciences | 2024-05-16 | 30 | 0 |
| K230131 | ReShape Calibration Tubes | Reshape Lifesciences | 2023-02-15 | 29 | 0 |
| K221898 | Gastrointestinal Boundary Identifier (GIBI HD) | Reshape Lifesciences | 2022-07-28 | 28 | 0 |
| K220455 | Lap-Band System Calibration Tube | Reshape Lifesciences | 2022-06-07 | 110 | 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