510(k) Report

FDA applicant

Cytrellis Biosystems, Inc.

Woburn, MA2 decisions2021–20252 recalls

FDA records 2 decisions for Cytrellis Biosystems, Inc. (Woburn, MA) from 2021 to 2025: 2 510(k) clearances. All are in product code QAI (Powered Microneedle Device). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are 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 Cytrellis Biosystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12025: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

2in 2023

2023: 2
2021high 2 (2023) · low 0 (2021)2026

Class I Class II/III not classified

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

Planning a device like Cytrellis Biosystems, 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?

  • QAIPowered Microneedle Device2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K202517Cytrellis Dermal Micro-Coring SystemCytrellis Biosystems, Inc. · 20212cite it

What has FDA decided for it lately?

  • K252752ellacor System with Micro-Coring TechnologyCytrellis Biosystems, Inc. · 2025
  • K202517Cytrellis Dermal Micro-Coring SystemCytrellis Biosystems, Inc. · 20212 recalls

All 2 as Cytrellis Biosystems, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K202517ellacor System with Micro-Coring Technology-Indicated for use by medical professionals…Jun 23, 2023Class II
  • K202517Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System…Apr 7, 2023Class II