510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K101988Substantially Equivalent

Heal Force CO2 Incubator

Shanghai Lishen Scientific Equipment Co., Ltd., Echo OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101988 is the FDA 510(k) clearance record for HEAL FORCE CO2 INCUBATOR, a class II device, cleared for Shanghai Lishen Scientific Equipment Co., Ltd. on under FDA product code MQG (Accessory, Assisted Reproduction). FDA records list one 510(k) clearance for Shanghai Lishen Scientific Equipment Co., Ltd. As of , FDA records show no recalls naming K101988.

Clearance record

Decision date
Received
(209 days to decision)
Product code
MQG Accessory, Assisted Reproduction
Regulation
21 CFR 884.6120
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Shanghai Lishen Scientific Equipment Co., Ltd. 77325 Joyce Way, Echo OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQG

Trailing 12 months
2 clearances under product code MQG in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260