510(k) Report

FDA applicant

Hollister, Inc.

Libertyville, IL100 decisions1977–20264 recalls

FDA records 100 decisions for Hollister, Inc. (Libertyville, IL) from 1977 to 2026: 100 510(k) clearances. Most are in product codes EXB (Collector, Ostomy) and GBM (Catheter, Urethral). Since 2016 its 510(k)s took a median of 143 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 68 predicates, 45 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Hollister Incorporated”.

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

FDA decisions per year

1in 2025

2009: 22010: 12011: 12013: 12014: 12015: 22017: 12018: 22019: 22022: 32024: 12025: 12026 (partial year): 1
2007high 3 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2015: 22021: 12026 (partial year): 1
2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Hollister, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hollister, 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?

  • EXBCollector, Ostomy14decisions
  • GBMCatheter, Urethral11decisions
  • KPIStimulator, Electrical, Non-Implantable, For Incontinence10decisions
  • ILOPack, Hot Or Cold, Water Circulating7decisions
  • KNTTubes, Gastrointestinal (And Accessories)7decisions
  • FRODressing, Wound, Drug6decisions

Also: EZD (5), FMQ (4), KNX (4), HIR (4), KOZ (2), EXI (2).

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 143 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 130 days; 5 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 68 predicates; 45 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 88 times; 45 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.

  • K891773Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 19899cite it
  • K930530Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 19957cite it
  • K950531Egnell EliteHollister, Inc. · 19955cite it
  • K961872Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 19965cite it
  • K974048Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 19975cite it
  • K141642Vapro Intermittent CatheterHollister Incorporated · 20144cite it

What has FDA decided for it lately?

  • K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated · 2026
  • K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved…Hollister Incorporated · 2025
  • K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved…Hollister Incorporated · 2024
  • K220667Sleeved ICHollister Incorporated · 2022
  • K213575Female IC (Not Finalized)Hollister Incorporated · 2022
  • K211436Intermittent Catheter (Not Finalized)Hollister Incorporated · 20221 recall
  • K193148VaPro Plus Pocket, VaPro PlusHollister Incorporated · 2019
  • K191633Infyna ChicHollister Incorporated · 2019

All 85 as Hollister, Inc. →All 15 as Hollister Incorporated →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K211436Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli…Jul 14, 2026Class II
  • K932855Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) -…Feb 11, 2021Class II
  • K011519Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging…Feb 12, 2015Class II
  • K912355Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with…Feb 12, 2015Class II