510(k) Report

FDA applicant

Molli Surgical, Inc.

Toronto, CA5 decisions2021–20241 recall

FDA records 5 decisions for Molli Surgical, Inc. (Toronto, CA) from 2021 to 2024: 5 510(k) clearances. All are in product code NEU (Marker, Radiographic, Implantable). Since 2016 its 510(k)s took a median of 148 days from receipt to decision, against 136 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Molli Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2021: 12023: 22024: 2
2021high 2 (2023) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2021high 1 (2026) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Molli Surgical, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • NEUMarker, Radiographic, Implantable5decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 148 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 136 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 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.

  • K231579MOLLI 2Molli Surgical, Inc. · 20232cite it
  • K223107MOLLI 2Molli Surgical, Inc. · 20231cites it
  • K210600MOLLIMolli Surgical, Inc. · 20211cites it
  • K240042MOLLI 2 SystemMolli Surgical, Inc. · 20241cites it

What has FDA decided for it lately?

  • K234149MOLLI 2 SystemMolli Surgical, Inc. · 2024
  • K240042MOLLI 2 SystemMolli Surgical, Inc. · 2024
  • K231579MOLLI 2Molli Surgical, Inc. · 20231 recall
  • K223107MOLLI 2Molli Surgical, Inc. · 2023
  • K210600MOLLIMolli Surgical, Inc. · 2021

All 5 as Molli Surgical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K231579MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and…Jan 21, 2026Class II