Sabratek Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Sabratek Corp.” (first 1992, latest 1999), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 200 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 |
|---|---|---|---|
| FRN | Pump, Infusion | 4 | 4 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- General Hospital (6)
- Cardiovascular (1)
Most recent Sabratek Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983355 | SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR | FLL | 1999-03-12 | 170 |
| K980751 | SABRATEK 4040 INFUSION PUMP | FRN | 1999-02-24 | 363 |
| K980619 | SABRATEK PATIENT HOME MANAGEMENT SYSTEM | MHX | 1998-08-20 | 183 |
| K955258 | 3030 INFUSION PUMP | FRN | 1996-06-03 | 200 |
| K944293 | SABRATEK SABSIL SETS | FPA | 1995-03-23 | 202 |
| K941984 | SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP | FRN | 1994-07-19 | 85 |
| K914589 | SABRATEK 3030 INFUSION PUMP | FRN | 1992-05-18 | 215 |
Recalls
openFDA lists no recalls under a recalling firm named Sabratek Corp..
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 Sabratek 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 Sabratek Corp.?
FDA lists 7 510(k) clearances under the applicant name “Sabratek Corp.” (first 1992, latest 1999), 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 Sabratek Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sabratek Corp. is 200 days.
Which FDA product codes appear under Sabratek Corp.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 4); FLL (Continuous Measurement Thermometer, 1); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 7 Sabratek Corp. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Sabratek 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.