510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K900213Substantially Equivalent

Pacemaker Patient Adaptor Module (Ppam)

Bomed Medical Mfg., Ltd., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900213 is the FDA 510(k) clearance record for PACEMAKER PATIENT ADAPTOR MODULE (PPAM), a class II device, cleared for Bomed Medical Mfg., Ltd. on under FDA product code DSB (Plethysmograph, Impedance). FDA records list 2 510(k) clearances for Bomed Medical Mfg., Ltd., from to . As of , FDA records show no recalls naming K900213.

Clearance record

Decision date
Received
(162 days to decision)
Product code
DSB Plethysmograph, Impedance
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Bomed Medical Mfg., Ltd. 15 Musick, Irvine CA
Third party review
No

Clearances, product code DSB

Trailing 12 months
2 clearances under product code DSB in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSB, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260