Penlon, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Penlon, Inc.” (first 1980, latest 2006), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 100 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 |
|---|---|---|---|
| CAD | Vaporizer, Anesthesia, Non-Heated | 7 | 7 |
| BSZ | Gas-Machine, Anesthesia | 3 | 3 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 3 | 3 |
| BSF | Absorber, Carbon-Dioxide | 1 | 1 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| CCW | Laryngoscope, Rigid | 1 | 1 |
| DWJ | System, Thermal Regulating | 1 | 1 |
Review panels
- Anesthesiology (18)
- Cardiovascular (1)
Most recent Penlon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061102 | PRIMA ANAESTHESIA MACHINE | BSZ | 2006-07-28 | 100 |
| K041076 | DELTA T | CAD | 2004-08-09 | 105 |
| K010318 | PRIMA OXYGEN MONITOR | CCL | 2001-07-23 | 171 |
| K010317 | AV 800 VENTILATOR | CBK | 2001-07-23 | 171 |
| K002343 | SIGMA DELTA | CAD | 2001-06-08 | 311 |
| K961468 | QUIK-FIL VAPORIZER KEYED FILLER | CAD | 1996-07-16 | 90 |
| K960944 | PPV VAPORIZER (MODIFICATION) | CAD | 1996-04-02 | 49 |
| K953179 | CLM LARYNGOSCOPE | CCW | 1995-10-06 | 88 |
| K942545 | SIGMA ELITE | CAD | 1995-02-03 | 248 |
| K936046 | SIGMA ELITE | CAD | 1994-11-04 | 319 |
9 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2013-05-14.
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.
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.
- Penlon Limited (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Penlon, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Penlon, Inc.” (first 1980, latest 2006), across 9 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 Penlon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Penlon, Inc. is 100 days.
Which FDA product codes appear under Penlon, Inc.?
The most frequent FDA product codes under this applicant name are CAD (Vaporizer, Anesthesia, Non-Heated, 7); BSZ (Gas-Machine, Anesthesia, 3); CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm), 3).
Next steps
- See all 19 Penlon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAD, Penlon, 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.