510(k) Report

FDA applicant

Planer Plc

Pleasant Hill, CA2 decisions2004–20122 recalls

FDA records 2 decisions for Planer Plc (Pleasant Hill, CA) from 2004 to 2012: 2 510(k) clearances. All are in product code MQG (Accessory, Assisted Reproduction). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2022

2022: 2
2007high 2 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • MQGAccessory, Assisted Reproduction2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K032086Kryo Art Controlled Rate FreezerPlaner Plc · 20041cites it
  • K121566Planer BT37 IncubatorPlaner Plc · 20121cites it

What has FDA decided for it lately?

  • K121566Planer BT37 IncubatorPlaner Plc · 20122 recalls
  • K032086Kryo Art Controlled Rate FreezerPlaner Plc · 2004

All 2 as Planer Plc →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K121566Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop…Aug 12, 2022Class II
  • K121566Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop…Aug 12, 2022Class II