510(k) Report

FDA applicant

Pacific Hemostasis

Huntersville, NC29 decisions1978–20006 recalls

FDA records 29 decisions for Pacific Hemostasis (Huntersville, NC) from 1978 to 2000: 29 510(k) clearances. Most are in product codes GGN (Plasma, Coagulation Control) and GJS (Test, Time, Prothrombin). Its devices cite 11 predicates, 0 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

FIG. A — Illustration, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Pacific Hemostasis since 2007.

Recalls per year

2in 2025

2010: 12017: 22025: 2
2007high 2 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Pacific Hemostasis’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?

  • GGNPlasma, Coagulation Control5decisions
  • GJSTest, Time, Prothrombin5decisions
  • KQGInstrument, Coagulation2decisions
  • GHMTest, Sickle Cell2decisions
  • GJTPlasma, Coagulation Factor Deficient2decisions
  • GGCControl, Plasma, Abnormal2decisions

Also: JBQ (1), GIS (1), GIT (1), LCP (1), JOZ (1), GIZ (1).

Whose devices does it build on?

Its devices cite 11 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 0 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.

  • K940082Thromboscreen Thromboplastin-DSPacific Hemostasis · 19953cite it
  • K891337Thromboscreen Aptt ReagentPacific Hemostasis · 19892cite it
  • K992279Heparin Control Plasma Level 2Pacific Hemostasis · 19991cites it
  • K781880Assay Kit, Thrombo-ScreenPacific Hemostasis · 19781cites it
  • K820450ThromboscreenPacific Hemostasis · 19821cites it
  • K994100Pacific Hemostasis Thromboplastin DPacific Hemostasis · 20001cites it

What has FDA decided for it lately?

  • K000679Thrombostrate Control PlasmasPacific Hemostasis · 2000
  • K994100Pacific Hemostasis Thromboplastin DPacific Hemostasis · 20002 recalls
  • K992130Pacific Hemostasis Thromboscreen 400CPacific Hemostasis · 1999
  • K992279Heparin Control Plasma Level 2Pacific Hemostasis · 1999
  • K992278Heparin Control Plasma Level 1Pacific Hemostasis · 1999
  • K991321Pacific Hemostasis Thromboscreen 200Pacific Hemostasis · 1999
  • K990046Pacific Hemostasis Immunodepleted Factor Viii Deficient PlasmaPacific Hemostasis · 1999
  • K984129Coagulation Control Level 1 (Normal)Pacific Hemostasis · 1998

All 29 as Pacific Hemostasis →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K994100Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin…Mar 6, 2025Class II
  • K994100Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time…Mar 6, 2025Class II
  • K800826Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations)…May 19, 2017Class II
  • K800826Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5…May 19, 2017Class II
  • K940082Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed…Oct 6, 2010
  • K854079Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher…Sep 3, 2004