# Hollister, Inc.

- Location (FDA's records): Libertyville, IL
- FDA decisions: 100 (1977–2026): 100 510(k) clearances
- Names in FDA's records: Hollister, Inc. (85); Hollister Incorporated (15)
- Product codes: EXB (14), GBM (11), KPI (10), ILO (7), KNT (7), FRO (6), EZD (5), FMQ (4), KNX (4), HIR (4), KOZ (2), EXI (2)
- 510(k) review time since 2016: median 143 days, against 130 for FDA's reviews in the same codes and years (5 of 9 faster)
- Predicates its devices cite: 68 (45 its own); citations of its devices by later devices: 88 (45 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Thermo Temp, Inc.: 4 (https://510kreport.com/company/thermo-temp)
- Dan Med, Inc.: 2 (https://510kreport.com/company/dan-med)
- The Prometheus Group: 2 (https://510kreport.com/company/prometheus-group)
- Bowel Management Systems, LLC: 2 (https://510kreport.com/company/bowel-management-systems)
- Mentor Corp.: 2 (https://510kreport.com/company/mentor)
- Carrington Laboratories, Inc.: 1 (https://510kreport.com/company/carrington-laboratories)
- Dpt Laboratories, Ltd.: 1 (https://510kreport.com/company/dpt-laboratories)
- Derma Sciences, Inc.: 1 (https://510kreport.com/company/derma-sciences)

## Firms that cite its devices most
- Mega Electronics, Ltd.: 5 (https://510kreport.com/company/mega-electronics)
- C.R. Bard, Inc.: 3 (https://510kreport.com/company/cr-bard)
- The Prometheus Group: 3 (https://510kreport.com/company/prometheus-group)
- Fuji Dynamics Limited: 2 (https://510kreport.com/company/fuji-dynamics)
- Empi: 2 (https://510kreport.com/company/empi)
- Evenflo Company, Inc.: 2 (https://510kreport.com/company/evenflo)
- Playtex Products, Inc.: 2 (https://510kreport.com/company/playtex-products)
- Medela AG: 2 (https://510kreport.com/company/medela)

## Its most-cited devices
- K891773: Microgyn II Elec Stim Device Treat of Urin Inconti (1989), cited by 9
- K930530: Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc (1995), cited by 7
- K950531: Egnell Elite (1995), cited by 5
- K961872: Incare Pelvic Floor Therapy System with Desktop Computer (1996), cited by 5
- K974048: Incare Pelvic Floor Therapy System with Desktop Computer (1997), cited by 5
- K141642: Vapro Intermittent Catheter (2014), cited by 4

## Recent decisions
- K253295: Coude Sleeved IC; Coude Plus Sleeved IC (May 18, 2026)
- K251468: Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) (Oct 3, 2025)
- K233524: Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) (May 3, 2024)
- K220667: Sleeved IC (Dec 8, 2022)
- K213575: Female IC (Not Finalized) (Sep 13, 2022)
- K211436: Intermittent Catheter (Not Finalized) (Jan 27, 2022)
- K193148: VaPro Plus Pocket, VaPro Plus (Dec 13, 2019)
- K191633: Infyna Chic (Jul 19, 2019)

Source page: https://510kreport.com/company/hollister