Atlas FDA

PADPRO MODEL #2516

FDA 510(k) clearance K020203 · decided 2002-05-08

Clearance details

K-number
K020203
Device name
PADPRO MODEL #2516
Applicant
Padpro, LLC
Decision
Substantially Equivalent
Date received
2002-01-22
Decision date
2002-05-08
Days to decision
106 days
Clearance type
Special
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Deer Field, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Padpro

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Powerheart G5 AED (K143714)Cardiac Science Corporation2015-05-04
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (K150198)Bio-Detek, Inc.2015-05-02
OneStep Pediatric CPR Multi-Function Electrode (K150055)Bio-Detek, Inc.2015-05-02
samaritan PAD 450P (K142709)Heartsine Technologies, Inc.2015-03-27
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (K133659)Philips Medical Systems2015-01-23
ZOLL E SERIES (K133239)Zoll Medical Corporation, World Wide Headquarters2015-01-16
LIFEPAK 15 monitor/defibrillator (K142430)Physio-Control, Inc.2014-12-19
BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (K141795)R & D Batteries, Inc.2014-12-08
ZOLL X Series (K142915)ZOLL Medical Corporation2014-12-03
Skintact, various other tradenames (K142803)Leonhard Lang GmbH2014-12-02
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY (K141231)Zeller Power Products (Battery Beast, LLC)2014-11-25
ZOLL X SERIES (K141774)ZOLL Medical Corporation2014-11-19

Recalls involving this device

RecordFirmDate
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHIL recall (Z-0457-2015)ConMed Corporation2014-12-04
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO P recall (Z-0458-2015)ConMed Corporation2014-12-04
PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/Mo recall (Z-0756-2007)Conmed Corporation2007-04-24
PADPRO ADULT Radiotranslucent Pad w/Medtronic connector, REF/Catalog #2516M. RX ONLY. Defi recall (Z-0757-2007)Conmed Corporation2007-04-24