# Innovative Health, LLC

- Location (FDA's records): Scottsdale, AZ
- FDA decisions: 51 (2016–2026): 51 510(k) clearances
- Names in FDA's records: Innovative Health, LLC (49); Innovative Health (2)
- Product codes: NLH (24), OWQ (7), DRF (6), PNE (5), NLG (3), QLZ (2), NMK (2), NLI (1), MTD (1)
- 510(k) review time since 2016: median 141 days, against 133 for FDA's reviews in the same codes and years (14 of 27 faster)
- Predicates its devices cite: 78 (11 its own); citations of its devices by later devices: 12 (11 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- St Jude Medical: 15 (https://510kreport.com/company/st-jude-medical)
- Biosense Webster, Inc.: 12 (https://510kreport.com/company/biosense-webster)
- Irvine Biomedical, Inc.: 10 (https://510kreport.com/company/irvine-biomedical)
- C.R. Bard, Inc.: 4 (https://510kreport.com/company/cr-bard)
- Baylis Medical Co., Inc.: 4 (https://510kreport.com/company/baylis-medical)
- Cordis Webster, Inc.: 3 (https://510kreport.com/company/cordis-webster)
- Volcano Corporation: 2 (https://510kreport.com/company/volcano)
- Daig Corp.: 2 (https://510kreport.com/company/daig)

## Firms that cite its devices most
- Northeast Scientific, Inc.: 1 (https://510kreport.com/company/northeast-scientific)

## Its most-cited devices
- K210655: Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (2022), cited by 1
- K190980: Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (2019), cited by 1
- K161464: Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters (2016), cited by 1
- K161827: Reprocessed Response Diagnostic Electrophysiology Catheters (2016), cited by 1
- K200060: Reprocessed NRG Transseptal Needle (2020), cited by 1
- K170922: Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) (2017), cited by 1

## Recent decisions
- K262917: Reprocessed BRK Transseptal Needle (Oct 19, 2026)
- K250305: Reprocessed Agilis NxT Steerable Introducer (Jan 7, 2026)
- K231015: Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters (Jul 1, 2024)
- K233825: Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (Jun 7, 2024)
- K232037: Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath (Apr 4, 2024)
- K230376: Reprocessed Agilis NxT Steerable Introducer (Aug 7, 2023)
- K213584: Reprocessed NRG Transseptal Needle (Apr 4, 2023)
- K221854: Reprocesses Umbilical Cable (Aug 6, 2022)

Source page: https://510kreport.com/company/innovative-health