510(k) Report

FDA applicant

AbbVie, Inc.

North Chicago, IL7 decisions2014–20264 recalls

FDA records 7 decisions for AbbVie, Inc. (North Chicago, IL) from 2014 to 2026: 7 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and LCJ (Tissue Expander And Accessories). Its devices cite 7 predicates, 3 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “AbbVie”.

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 AbbVie, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2015

2014: 32015: 32026 (partial year): 1
2014high 3 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

3in 2017

2016: 12017: 3
2014high 3 (2017) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — AbbVie, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like AbbVie, 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?

  • KNTTubes, Gastrointestinal (And Accessories)6decisions
  • LCJTissue Expander And Accessories1decision

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K133129Abbvie NJAbbVie, Inc. · 20141cites it
  • K133096Abb Vie JAbbVie, Inc. · 20141cites it
  • K133087Abbvie PegAbbVie, Inc. · 20141cites it

What has FDA decided for it lately?

  • K254126Natrelle 133S Tissue ExpandersAbbVie · 2026
  • K142792AbbVie NJAbbVie, Inc. · 2015
  • K142816AbbVie JAbbVie, Inc. · 2015
  • K142793AbbVie PEGAbbVie, Inc. · 20154 recalls
  • K133129Abbvie NJAbbVie, Inc. · 2014
  • K133087Abbvie PegAbbVie, Inc. · 2014
  • K133096Abb Vie JAbbVie, Inc. · 2014

All 6 as AbbVie, Inc. →The one decision as AbbVie →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K142793AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.Apr 27, 2017Class II
  • K142793AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.Apr 27, 2017Class II
  • K142793AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.Apr 27, 2017Class II
  • K142793AbbVie PEG Kit 20 FRNov 22, 2016Class II