510(k) Report

FDA applicant

Kendro Laboratory Products, L.P.

Great Neck, NY2 decisions2000–20030 recalls

FDA records 2 decisions for Kendro Laboratory Products, L.P. (Great Neck, NY) from 2000 to 2003: 2 510(k) clearances. All are in product code MQG (Accessory, Assisted Reproduction). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Kendro Laboratory Products, L.P.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kendro Laboratory Products, L.P. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kendro Laboratory Products, L.P. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kendro Laboratory Products, L.P.’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?

  • MQGAccessory, Assisted Reproduction2decisions

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K002805Kendro Heracell CO2 IncubatorKendro Laboratory Products, L.P. · 20003cite it
  • K023465Kendro Heracell 240 IncubatorKendro Laboratory Products, L.P. · 20031cites it

What has FDA decided for it lately?

  • K023465Kendro Heracell 240 IncubatorKendro Laboratory Products, L.P. · 2003
  • K002805Kendro Heracell CO2 IncubatorKendro Laboratory Products, L.P. · 2000

All 2 as Kendro Laboratory Products, L.P. →