Reshape Lifesciences: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Reshape Lifesciences” (first 2022, latest 2024), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 30 days. Since 2017 the median was 30 days, against 138 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2022 | 2 | 69 |
| 2023 | 1 | 29 |
| 2024 | 1 | 30 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Reshape Lifesciences took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 4 | 4 |
| PIM | Neuromodulator For Obesity | 1 | 0 |
Review panels
Most recent Reshape Lifesciences 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241039 | ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) | KNT | 2024-05-16 | 30 |
| K230131 | ReShape Calibration Tubes | KNT | 2023-02-15 | 29 |
| K221898 | Gastrointestinal Boundary Identifier (GIBI HD) | KNT | 2022-07-28 | 28 |
| K220455 | Lap-Band System Calibration Tube | KNT | 2022-06-07 | 110 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130019 | PMA | MAESTRO RECHARGEABLE SYSTEM | 2015-01-14 |
Recalls
openFDA lists no recalls under a recalling firm named Reshape Lifesciences.
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.
Device clinical trials
An industry sponsor named Reshape Lifesciences is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01673698: A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects (Completed, started 2012-08)
- NCT01061385: The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects (Completed, started 2010-02)
- NCT01024465: ReShape Intragastric Balloon for the Treatment of Obesity (Completed, started 2009-09)
- NCT00521079: EMPOWER Clinical Trial: Vagal Blocking for Obesity Control (Completed, started 2007-08)
Frequently asked questions
How many FDA 510(k) clearances are listed under Reshape Lifesciences?
FDA lists 4 510(k) clearances under the applicant name “Reshape Lifesciences” (first 2022, latest 2024), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Reshape Lifesciences?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reshape Lifesciences is 30 days. Since 2017: 30 days, versus 138 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Reshape Lifesciences?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 4); PIM (Neuromodulator For Obesity, 1).
Next steps
- See all 4 Reshape Lifesciences clearances with predicates and recalls
- Run predicate analysis for product code KNT, Reshape Lifesciences'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.