510(k) Report

FDA applicant

Reshape Lifesciences

San Clemente, CA5 decisions2015–20240 recalls

FDA records 5 decisions for Reshape Lifesciences (San Clemente, CA) from 2015 to 2024: 4 510(k) clearances and 1 original PMA approval. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and PIM (Neuromodulator For Obesity). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Reshape Lifesciences, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Reshape Lifesciences’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2015: 12022: 22023: 12024: 1
2015high 2 (2022) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Reshape Lifesciences by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Reshape Lifesciences’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KNTTubes, Gastrointestinal (And Accessories)4decisions
  • PIMNeuromodulator For Obesity1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 30 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 110 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K221898Gastrointestinal Boundary Identifier (GIBI HD)Reshape Lifesciences · 20222cite it
  • K220455Lap-Band System Calibration TubeReshape Lifesciences · 20222cite it

What has FDA decided for it lately?

  • K241039ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon…Reshape Lifesciences · 2024
  • K230131ReShape Calibration TubesReshape Lifesciences · 2023
  • K221898Gastrointestinal Boundary Identifier (GIBI HD)Reshape Lifesciences · 2022
  • K220455Lap-Band System Calibration TubeReshape Lifesciences · 2022
  • P130019Maestro Rechargeable SystemReshape Lifesciences, Inc. · 2015

All 4 as Reshape Lifesciences →The one decision as Reshape Lifesciences, Inc. →