Polamedco, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Polamedco, Inc.” (first 1978, latest 1999), across 11 product codes in 5 review panels. Median 510(k) review time under this name: 48 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 7 | 7 |
| BSR | Stylet, Tracheal Tube | 2 | 2 |
| BTQ | Airway, Nasopharyngeal | 2 | 2 |
| BZA | Connector, Airway (Extension) | 2 | 2 |
| BSS | Tube, Nasogastric | 1 | 1 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 | 1 |
| FWZ | Operating Room Accessories Table Tray | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (15)
- Gastroenterology and Urology (1)
- General Hospital (1)
- Obstetrics and Gynecology (1)
- General and Plastic Surgery (1)
Most recent Polamedco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983000 | CRICOTHYROTOMY TUBE | BTO | 1999-10-27 | 426 |
| K954383 | SURELOC CIRCUIT CONNECTOR | BZA | 1995-12-22 | 94 |
| K953793 | INTROSCOPE | BZT | 1995-11-29 | 107 |
| K950713 | AIRGUIDE STYLETTE | BSR | 1995-05-17 | 91 |
| K933596 | GASTRIC, CATHETER, IRRIGATION & ASPIRATION | BSS | 1995-02-13 | 567 |
| K950380 | FLEXTITIP STYLETTE | BSR | 1995-02-10 | 10 |
| K920900 | POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES | BTR | 1992-03-18 | 21 |
| K900456 | POLAMEDCO NASOPAHARYNGEAL AIRWAY | BTQ | 1990-04-19 | 79 |
| K900457 | CUFFED LINDER NASOTRACHEAL AIRWAY | BTR | 1990-04-16 | 76 |
| K894516 | VISOSHIELD(TM), SURGICAL EYE PROTECTOR | FXX | 1989-09-12 | 55 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Polamedco, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Polamedco, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Polamedco, Inc.” (first 1978, latest 1999), across 11 product codes in 5 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 Polamedco, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Polamedco, Inc. is 48 days.
Which FDA product codes appear under Polamedco, Inc.?
The most frequent FDA product codes under this applicant name are BTR (Tube, Tracheal (W/Wo Connector), 7); BSR (Stylet, Tracheal Tube, 2); BTQ (Airway, Nasopharyngeal, 2).
Next steps
- See all 20 Polamedco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTR, Polamedco, 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, 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.