FDA product code BSS: Tube, Nasogastric
BSS is the FDA product code for tube, nasogastric. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 13 510(k) submissions under BSS, from 13 different applicants. The average 510(k) review took 261 days (median 143). FDA has posted 5 recalls for BSS devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Nasogastric |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every BSS clearance
Top BSS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Turboseal, L.P. | 1 | 2014-12-19 |
| Biosearch Medical Products, Inc. | 1 | 2005-10-12 |
| Moss Tubes, Inc. | 1 | 1999-03-02 |
| B.Braun Medical, Inc. | 1 | 1997-06-11 |
| Polamedco, Inc. | 1 | 1995-02-13 |
8 more applicants have BSS clearances. See the full list in Caduvo.
Most recent BSS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142483 | Turboseal, L.P. | TurboSEAL Nasogastric Aspiration Tube | 2014-12-19 | 106 |
| K051480 | Biosearch Medical Products, Inc. | ENTERAL FEEDING TUBE | 2005-10-12 | 131 |
| K984629 | Moss Tubes, Inc. | MOSS TUBES, INC. NASAL TUBE - MARK IV | 1999-03-02 | 62 |
| K961711 | B.Braun Medical, Inc. | ASPISAFE GASTRIC TUBE | 1997-06-11 | 405 |
| K933596 | Polamedco, Inc. | GASTRIC, CATHETER, IRRIGATION & ASPIRATION | 1995-02-13 | 567 |
Recalls for BSS devices
5 product recalls in 1 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2023-12-20.
| Year | Recalls |
|---|---|
| 2023 | 5 |
Frequently asked questions
What is FDA product code BSS?
BSS is the FDA product code for tube, nasogastric. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is BSS?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code BSS?
Across 13 cleared submissions the average was 261 days from receipt to decision (median 143).
Which companies have the most BSS clearances?
Turboseal, L.P. (1); Biosearch Medical Products, Inc. (1); Moss Tubes, Inc. (1); B.Braun Medical, Inc. (1); Polamedco, Inc. (1).
Have BSS devices been recalled?
Yes: 5 product recalls across 1 recall events; the most recent began 2023-12-20.
Next steps
- Run an FDA pathway report with predicate devices for product code BSS
- Run a recall and safety report across every BSS manufacturer
- Watch product code BSS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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