510(k) Report

FDA applicant

Hem Con Medical Technologies, Inc.

Portland, OR9 decisions2008–20166 recalls

FDA records 9 decisions for Hem Con Medical Technologies, Inc. (Portland, OR) from 2008 to 2016: 9 510(k) clearances. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 28 predicates, 12 of them its own earlier devices. 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Hem Con Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2008: 22009: 22010: 12011: 22015: 12016: 1
2008high 2 (2008) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2012

2011: 52012: 1
2008high 5 (2011) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Hem Con Medical Technologies, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hem Con Medical Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics9decisions

Whose devices does it build on?

Its devices cite 28 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 12 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.

  • K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 20097cite it
  • K072486Modification to Hemcon Bandage and Hemcon Bandage OtcHem Con Medical Technologies, Inc. · 20084cite it
  • K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 20084cite it
  • K092357Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY, Chitogauze, Packaging…Hem Con Medical Technologies, Inc. · 20093cite it
  • K102546ChitogauzeHem Con Medical Technologies, Inc. · 20103cite it
  • K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PROHem Con Medical Technologies, Inc. · 20152cite it

What has FDA decided for it lately?

  • K153582Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc. · 2016
  • K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PROHem Con Medical Technologies, Inc. · 2015
  • K103641GuardacareHem Con Medical Technologies, Inc. · 2011
  • K111163Chitogauze FusionHem Con Medical Technologies, Inc. · 2011
  • K102546ChitogauzeHem Con Medical Technologies, Inc. · 2010
  • K092357Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY, Chitogauze, Packaging…Hem Con Medical Technologies, Inc. · 2009
  • K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
  • K072486Modification to Hemcon Bandage and Hemcon Bandage OtcHem Con Medical Technologies, Inc. · 20086 recalls

All 9 as Hem Con Medical Technologies, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K072486ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator).…Apr 3, 2012
  • K060226ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear…May 25, 2011
  • K072486ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator).…Apr 15, 2011
  • K060226ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in…Mar 31, 2011
  • K060226ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2…Mar 31, 2011
  • K060226ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to…Mar 24, 2011