510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K873806Substantially Equivalent

Jdm Sp2 Sensor

Jd Monitoring C/O Mackler, Cooper and Gibbs, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873806 is the FDA 510(k) clearance record for JDM SP2 SENSOR, a class I device, cleared for Jd Monitoring C/O Mackler, Cooper and Gibbs on under FDA product code KMI (Monitor, Bed Patient). FDA records list one 510(k) clearance for Jd Monitoring C/O Mackler, Cooper and Gibbs. As of , FDA records show 4 recalls naming K873806.

Clearance record

Decision date
Received
(81 days to decision)
Product code
KMI Monitor, Bed Patient
Regulation
21 CFR 880.2400
Device class
Class I
Review panel
General Hospital
Applicant
Jd Monitoring C/O Mackler, Cooper and Gibbs Suite 615, Washington DC
Third party review
No

Clearances, product code KMI

Trailing 12 months

FDA records hold no clearances under product code KMI in the trailing twelve months.

FDA records show no clearances under product code KMI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260