FDA product code LRQ: Tracheostomy And Nasal Suctioning Kit
LRQ is the FDA product code for tracheostomy and nasal suctioning kit. It is a Class I device, reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under LRQ, from 6 different applicants. The average 510(k) review took 59 days (median 52). FDA has posted 4 recalls for LRQ devices, 2 initiated in the last five years.
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Tracheostomy And Nasal Suctioning Kit |
| Device class | Class I |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LRQ clearance
Top LRQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Grand Medical Products | 1 | 1996-11-27 |
| Medcare Medical Group, Inc. | 1 | 1996-07-02 |
| Contour Fabricators of Florida, Inc. | 1 | 1995-07-12 |
| Premium Plastics, Inc. | 1 | 1995-06-21 |
| Automatic Liquid Packaging, Inc. | 1 | 1987-06-01 |
1 more applicants have LRQ clearances. See the full list in Caduvo.
Most recent LRQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963720 | Grand Medical Products | TRACHEOSTOMY KIT | 1996-11-27 | 72 |
| K961167 | Medcare Medical Group, Inc. | MEDCARE TRACHEOSTOMY CARE TRAY | 1996-07-02 | 99 |
| K952925 | Contour Fabricators of Florida, Inc. | READY NURSE SYSTEM (RNS) TRACH CARE KIT | 1995-07-12 | 16 |
| K950851 | Premium Plastics, Inc. | GENT-L-KARE TRACHEOSTOMY TRAYS | 1995-06-21 | 117 |
| K871692 | Automatic Liquid Packaging, Inc. | TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1 | 1987-06-01 | 33 |
Recalls for LRQ devices
4 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-11-15.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code LRQ?
LRQ is the FDA product code for tracheostomy and nasal suctioning kit. It is a Class I device, reviewed by the General and Plastic Surgery panel.
What device class is LRQ?
Class I. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRQ?
Across 6 cleared submissions the average was 59 days from receipt to decision (median 52).
Which companies have the most LRQ clearances?
Grand Medical Products (1); Medcare Medical Group, Inc. (1); Contour Fabricators of Florida, Inc. (1); Premium Plastics, Inc. (1); Automatic Liquid Packaging, Inc. (1).
Have LRQ devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2023-11-15.
Next steps
- Run an FDA pathway report with predicate devices for product code LRQ
- Run a recall and safety report across every LRQ manufacturer
- Watch product code LRQ 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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