510(k) Report

FDA applicant

Benlan, Inc.

Oakville, CA7 decisions1999–20147 recalls

FDA records 7 decisions for Benlan, Inc. (Oakville, CA) from 1999 to 2014: 7 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FPD (Tube, Feeding). Its devices cite 7 predicates, 0 of them its own earlier devices. 7 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 hospital panel, where it files most

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

FDA decisions per year

1in 2014

2010: 22011: 12012: 12014: 1
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2015: 12018: 32019: 22022: 1
2007high 3 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Benlan, 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?

  • FPASet, Administration, Intravascular4decisions
  • FPDTube, Feeding1decision
  • LJHSystem, Irrigation, Urological1decision
  • KNTTubes, Gastrointestinal (And Accessories)1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K131183Med-RX Oral/Enteral SyringeBenlan, Inc. · 2014
  • K120375Med-RX Patient Delivery SetBenlan, Inc. · 2012
  • K112799Med-RX Extension Set with T-ConnectorBenlan, Inc. · 2011
  • K100700Med-RX Pediatric Feeding Tubes and AccessoriesBenlan, Inc. · 20106 recalls
  • K102073Med-RX Transfer Set, Models 10-1227TS, 10-1300TS, 10-1305TS and 10-1306TSBenlan, Inc. · 2010
  • K010607Med-RX Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001Benlan, Inc. · 20011 recall
  • K990777Med-RX Extension SetsBenlan, Inc. · 1999

All 7 as Benlan, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K010607Med-RX Urological Cysto/Bladder Irrigation Set, Ref 10-4001Aug 19, 2022Class III
  • K100700DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF…Jul 22, 2019Class II
  • K100700MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16"…Jul 16, 2019Class II
  • K100700DeRoyal (R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral…Dec 17, 2018Class II
  • K100700MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and…Dec 1, 2018Class II
  • K100700MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use…Jun 11, 2018Class II