# Caldera Medical, Inc.

- Location (FDA's records): Agoura Hills, CA
- FDA decisions: 24 (2006–2023): 24 510(k) clearances
- Names in FDA's records: Caldera Medical, Inc. (22); Caldera Medical (2)
- Product codes: OTN (8), OTO (5), HIH (3), FTL (3), PAH (2), KCT (1), OTP (1), PWJ (1)
- 510(k) review time since 2016: median 228 days, against 112 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 24 (15 its own); citations of its devices by later devices: 23 (15 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
- ETHICON, Inc.: 3 (https://510kreport.com/company/ethicon)
- American Medical Systems, Inc.: 3 (https://510kreport.com/company/american-medical-systems)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Coloplast A/S: 1 (https://510kreport.com/company/coloplast-a-s)
- Herniamesh S.R.L.: 1 (https://510kreport.com/company/herniamesh)

## Firms that cite its devices most
- Coloplast Corp.: 2 (https://510kreport.com/company/coloplast)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Neomedic International S.L.: 1 (https://510kreport.com/company/neomedic-international)
- Generic Medical Device, Inc.: 1 (https://510kreport.com/company/generic-medical-device)
- Generic Medical Devices, Inc.: 1 (https://510kreport.com/company/generic-medical-devices)
- Marketing Solutions, Inc.: 1 (https://510kreport.com/company/marketing-solutions)
- Axora Medical, Inc.: 1 (https://510kreport.com/company/axora-medical)

## Its most-cited devices
- K072456: Desara Mesh Sling, Model Cal-DS01 (2008), cited by 4
- K120327: Vertessa (2012), cited by 3
- K101169: Desara Mesh Model: Cal-DS01 (2010), cited by 2
- K053424: Popmesh (2006), cited by 2
- K112609: Desara Mesh (2011), cited by 2
- K162201: Desara TV, Desara Blue TV (2017), cited by 1

## Recent decisions
- K233500: Benesta Tissue Removal Device (Nov 30, 2023)
- K211975: Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System (Nov 10, 2021)
- K192811: BenestaTM Tissue Removal Device (Oct 23, 2020)
- K192822: Benesta Hysteroscope (Sep 9, 2020)
- K193603: Benesta Medical Sterilization Tray (Jul 20, 2020)
- K191416: Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack (Feb 7, 2020)
- K172614: Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left (May 4, 2018)
- K162201: Desara TV, Desara Blue TV (Jan 11, 2017)

Source page: https://510kreport.com/company/caldera-medical