Sims Portex, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Sims Portex, Inc.” (first 1998, latest 2001), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under ICU Medical, based on public ownership records.
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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 | 1 |
| MIA | Needle, Spinal, Short Term | 1 | 1 |
Review panels
- Anesthesiology (7)
- General Hospital (4)
- Clinical Chemistry (1)
Most recent Sims Portex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011925 | HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO | FMI | 2001-07-12 | 22 |
| K002201 | ELECTROSTATIC HYDROPHOBIC BREATHING FILTER | CAH | 2001-02-05 | 200 |
| K002506 | BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT | CAH | 2000-12-14 | 121 |
| K001318 | CPAP SYSTEM, MODEL 102001 | BYE | 2000-07-20 | 85 |
| K993619 | CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK | BSP | 2000-04-28 | 185 |
| K994275 | SIMS PORTEX ANESTHESIA CATHETER | FRN | 2000-02-22 | 64 |
| K991861 | 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE | BTM | 2000-01-18 | 231 |
| K992471 | SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 | BSO | 1999-10-22 | 88 |
| K992057 | IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 | BTM | 1999-09-13 | 87 |
| K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | MIA | 1999-01-29 | 88 |
2 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2002-11-15.
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 Sims Portex, Inc. (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)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sims Deltec, Inc. (32 510(k)s)
- Sims Portex , Ltd. (4 510(k)s)
- Sims Surgical, Inc. (3 510(k)s)
- Sims (2 510(k)s)
- Sims Level 1, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sims Portex, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Sims Portex, Inc.” (first 1998, latest 2001), across 10 product codes in 3 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 Sims Portex, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sims Portex, Inc. is 88 days.
Which FDA product codes appear under Sims Portex, Inc.?
The most frequent FDA product codes under this applicant name are BTM (Ventilator, Emergency, Manual (Resuscitator), 2); CAH (Filter, Bacterial, Breathing-Circuit, 2); BSO (Catheter, Conduction, Anesthetic, 1).
Next steps
- See all 12 Sims Portex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTM, Sims Portex, Inc.'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.