510(k) · Cleared

Cleared

G210 InviCell Plus with SignipHy pH monitoring

K191020510(k) TraditionalCleared Jan 14, 2020272-day reviewClass II21 CFR 884.6120

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

CooperSurgical, Inc. · PUB Accessory, Assisted Reproduction, Exempt

Cleared on Jan 14, 2020 as substantially equivalent to K121566 (Planer Plc, 2012) after a 272-day review. Its family tree reaches back 2 generations to 1999.

Decided: Jan 14, 2020
Review: 272 days
Class: Class II
Product code: PUB
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K983642 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK983642 Cook Mini-IncubatorCook Ob/Gyn · 1999 · Recalled
1 generation backK121566 Planer BT37 IncubatorPlaner Plc · 2012 · Recalled
This deviceK191020 G210 InviCell Plus with SignipHy pH monitoringCooperSurgical, Inc. · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K983642	Cook Mini-Incubator	Cook Ob/Gyn	1999	3
−1	K121566	Planer BT37 Incubator	Planer Plc	2012	2
0 (this device)	K191020	G210 InviCell Plus with SignipHy pH monitoring	CooperSurgical, Inc.	2020	—

FIG. 1 — Lineage of K191020, 1999–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PUB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K121566	Planer BT37 Incubator Summary page 4 …es Product Code: PUB (Accessory, Assisted Reproduction, Exempt) Regulatory Class: II Predicate Device Information Trade Name: BT37 Incubator (510(k) number: K121566) Common Name: IVF Incubator Classification Name: Accessory, Assisted Reproduction (21 CFR 884.6120) Product Code: MQG The predic…	Planer Plc	2012	2

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 13.8 years on median.
2 of the 2 ancestors have a recall of any class.

How does its category compare?

All PUB devices

PUB Accessory, Assisted Reproduction, Exempt: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · PUB

1in 2020

2007high 1 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PUB

Too few PUB 510(k)s in any year since 2007 to give a median.

Recalls per year · PUB

6in 2024

2007high 6 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PUB

1in 2025

2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code PUB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	1
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	1
2020	1	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	1
2024	0	—	6	0
2025	0	—	0	1
2026	0	—	0	—

What is it indicated for?

The G210 InviCell Plus with SignipHy™ pH Monitoring System is a bench-top incubator that is intended to provide a controlled environment at or near body temperature and gas levels (CO2, O2, and N2) for the development of gametes and/or embryos during In Vitro Fertilization (IVF) / Assisted Reproductive Technology (ART) treatments.

The G210 InviCell Plus with SignipHy™ pH Monitoring System includes an accessory for pH monitoring of surrogate samples of bicarbonate-based culture media used for ART procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K191020 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191020: G210 InviCell Plus with SignipHy pH monitoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191020

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026