Ballard Medical Products: FDA clearances and approvals
Ballard Medical Products has 26 FDA 510(k) clearances (first 1982, latest 2003), across 19 product codes in 5 review panels. Median 510(k) review time: 80 days. openFDA lists 7 product recalls by a recalling firm named Ballard Medical Products.
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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 5 | 5 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 2 | 2 |
| GEC | Brush, Scrub, Operating-Room | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| BWH | Forceps, Biopsy, Bronchoscope (Non-Rigid) | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| BYH | Drain, Tee (Water Trap) | 1 | 1 |
| BYI | Percussor, Powered-Electric | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
Plus 9 more product codes.
Review panels
- Anesthesiology (12)
- General and Plastic Surgery (5)
- Gastroenterology and Urology (4)
- General Hospital (3)
- Ear, Nose and Throat (2)
Most recent Ballard Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030721 | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | LRO | 2003-03-31 | 24 |
| K022398 | REUSABLE BRONCHIAL BIOPSY FORCEPS | BWH | 2002-10-11 | 80 |
| K013892 | LUTZ NEEDLE | BSP | 2002-07-11 | 230 |
| K000495 | BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES | BSP | 2000-03-28 | 42 |
| K993138 | BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT | KNT | 1999-10-20 | 30 |
| K990376 | BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME | KNS | 1999-05-03 | 84 |
| K982894 | MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT | KNT | 1998-09-11 | 25 |
| K974630 | 72 HOUR USE TRACH CARE WITH MICROBAN | CAH | 1998-03-11 | 89 |
| K964369 | TRACH CARE SET WITH MICROBAN | BSY | 1997-02-11 | 102 |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | KDH | 1995-07-05 | 93 |
16 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-06-13.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Ballard Medical Products's product codes (a text match, not an official crosswalk):
- A4575 — Topical hyperbaric oxygen chamber, disposable (via KPJ)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
Frequently asked questions
How many FDA 510(k) clearances does Ballard Medical Products have?
Ballard Medical Products has 26 FDA 510(k) clearances (first 1982, latest 2003), across 19 product codes in 5 review panels.
How long does FDA take to clear Ballard Medical Products's 510(k)s?
The median time from FDA receipt to decision across Ballard Medical Products's cleared 510(k)s is 80 days.
What devices does Ballard Medical Products make?
Its most frequent FDA product codes are BSY (Catheters, Suction, Tracheobronchial, 5); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 2); GEC (Brush, Scrub, Operating-Room, 2).
Has Ballard Medical Products had device recalls?
openFDA lists 7 product recalls in 1 recall event by a recalling firm whose name matches Ballard Medical Products; the most recent began 2003-06-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 26 Ballard Medical Products clearances with predicates and recalls
- Run predicate analysis for product code BSY, Ballard Medical Products's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.