I-Flow Corp.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “I-Flow Corp.” (first 1988, latest 2007), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 71 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | 16 | 16 |
| FRN | Pump, Infusion | 13 | 13 |
| FPA | Set, Administration, Intravascular | 9 | 9 |
| BSO | Catheter, Conduction, Anesthetic | 3 | 3 |
Review panels
- General Hospital (38)
- Anesthesiology (3)
Most recent I-Flow Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP | MEB | 2007-01-26 | 65 |
| K063234 | ON-Q INTRODUCERS | BSO | 2006-11-21 | 27 |
| K051401 | ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER | BSO | 2005-11-30 | 183 |
| K052117 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) | MEB | 2005-09-09 | 36 |
| K043456 | MODIFICATION TO SOAKER CATHETER | BSO | 2005-01-11 | 27 |
| K040337 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) | MEB | 2004-05-24 | 103 |
| K023883 | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO | MEB | 2002-12-20 | 29 |
| K023827 | PARAGON INFUSION SYSTEM WITH BOLUS | FRN | 2002-12-13 | 25 |
| K023318 | I-FLOW ELASTOMERIC PUMP WITH BOLUS | MEB | 2002-10-18 | 14 |
| K022869 | SOAKER CATHETER | FRN | 2002-09-20 | 22 |
31 earlier clearances. See the full list in Caduvo.
Recalls
16 product recalls in 14 recall events; 0 initiated in the last five years. Most recent: 2012-05-08.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under I-Flow Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under I-Flow Corp.?
FDA lists 41 510(k) clearances under the applicant name “I-Flow Corp.” (first 1988, latest 2007), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by I-Flow Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name I-Flow Corp. is 71 days.
Which FDA product codes appear under I-Flow Corp.?
The most frequent FDA product codes under this applicant name are MEB (Pump, Infusion, Elastomeric, 16); FRN (Pump, Infusion, 13); FPA (Set, Administration, Intravascular, 9).
Next steps
- See all 41 I-Flow Corp. clearances with predicates and recalls
- Run predicate analysis for product code MEB, I-Flow Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.