510(k) Report

FDA applicant

Genzyme Corp.

Cambridge, MA35 decisions1991–201126 recalls

FDA records 35 decisions for Genzyme Corp. (Cambridge, MA) from 1991 to 2011: 33 510(k) clearances and 2 original PMA approvals. Most are in product codes JFJ (Catalytic Methods, Amylase) and FTL (Mesh, Surgical, Polymeric). Its devices cite 28 predicates, 8 of them its own earlier devices. 26 recalls are linked to its devices.

FDA’s records also spell it “Genzyme Corporation”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2011

2007: 12008: 12009: 12010: 12011: 1
2007high 1 (2007) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

6in 2014

2007: 12013: 192014: 6
2007high 19 (2013) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Genzyme Corp.’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?

  • JFJCatalytic Methods, Amylase4decisions
  • FTLMesh, Surgical, Polymeric3decisions
  • LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl3decisions
  • PSZDevices Detecting Influenza A, B, And C Virus Antigens3decisions
  • LBRLdl & Vldl Precipitation, Hdl3decisions
  • MRRSystem, Test, Low Density, Lipoprotein3decisions

Also: LCP (2), GGT (2), LYA (1), KHJ (1), FTM (1), LLH (1).

Whose devices does it build on?

Its devices cite 28 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 56 times; 8 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.

  • K021019Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 200212cite it
  • K021316Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol CalibratorGenzyme Corp. · 20027cite it
  • K971573N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL Cholesterol Control SetGenzyme Corp. · 19977cite it
  • K012532Sepragel SinusGenzyme Corp. · 20016cite it
  • K040868Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 20045cite it
  • K053066Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 20054cite it

What has FDA decided for it lately?

  • P110003LEGOOGenzyme Corp. · 201118 recalls
  • K102242Osom C. Difficile Toxin a/B TestGenzyme Corporation · 20101 recall
  • K092633Osom Influenza a&B Test , Model PN190Genzyme Corporation · 2009
  • K080662Genzyme Cystatin C Reagent Anf Genzyme Cystatin C CalibratorGenzyme Corporation · 2008
  • K063739Sepramesh, Model 5959-1214Genzyme Corporation · 2007
  • K061508Osom Influenza a&B TestGenzyme Corp. · 2006
  • K051244Genzyme Osom Influenza a & B TestGenzyme Corp. · 2006
  • K053066Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005

All 29 as Genzyme Corp. →All 6 as Genzyme Corporation →

What has been recalled?

26 recalls linked to its devices; the latest:

  • K021019Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage…Mar 11, 2014Class II
  • K021019Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage…Mar 11, 2014Class II
  • K021019Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only…Mar 11, 2014Class II
  • K021019Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable…Mar 11, 2014Class II
  • K021019Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage…Mar 11, 2014Class II
  • K021019Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage…Mar 11, 2014Class II

Other applicant names beginning “Genzyme”

FDA records each applicant name separately; these may or may not be the same firm.

Genzyme Surgical Product (Genzyme Biosurgery) 9Genzyme Diagnostics 5Genzyme Biosurgery 5Genzyme Diagnostics P.E.I., Inc. 2